LIST OF DRUGS DECLARED AS NOT OF STANDARD QUALITY BY DRUGS CONTROL LABORATORY, DCA, TELANGANA STATE |
S.No |
Drug Name |
Batch No. |
Manufacturing Date |
Expiry Date |
Manufacturer Name |
Manufacturer Address |
State |
Date of Report |
Remarks |
1 |
Fexotel-M Tablets, Fexofenadine and Montelukast Sodium Tablets |
FMT-10722 |
06/2022 |
05/2024 |
Cartel Laboratories |
Plot No. 10/A & 11/a., Chengicherla, Medchal- Malkajgiri Dist., Hyderabad-92 Telangana. |
Telangana |
28.04.2023 |
Disintegration test does not complies as per Manufacture method and IP. |
2 |
Nicemol-Plus Tablets, Nimesulide & Paracetamol Tablets |
NP210702 |
07/2022 |
06/2024 |
BRD Medilabs (Unit-II) |
19-20, DIC, Ind. Area Baddi, (HP) - 173205, Himachal Pradesh. |
Himachal Pradesh |
28.04.2023 |
Sample does not meet specification of Disintegration test as per Indian Pharmacopeia. |
3 |
CEFPOZAL-200-DT Tablets |
MMT-3843 |
04/2022 |
03/2024 |
Mayoford Pharma |
Near Railway Crossing, Chambhaghat, Solan, Dist-Solan , Himachal Pradesh-17213. |
Himachal Pradesh |
03-04-2023 |
Sample does not meet specification of Disintegration test as per Indian Pharmacopeia 2018. |
4 |
Mfpod-200 Tablets, Cefpodoxime Proxetil Tablets I.P. |
ABT220089 |
09/2022 |
08/2024 |
Alexa Pharmaceuticals |
Plat No. 20, ext-HPSIDC,Industrial area,Baddi, solan (H.P) 173205, Himachal Pradesh. |
Himachal Pradesh |
29-04-2023 |
Tablets Dose not meet the Assay and Dissolution Specifications as per IP 2022.The percentage drug release is below 33.94, Because the Tablets potency is 68.65 mg out of 200 mg.ie 34.32 Percentage only. |
5 |
Fepanil-250 Suspension, Paracetamol Pediatric Oral Suspension IP |
FLH22J51 |
09/2022 |
08/2024 |
HI-TECH Pharmaceuticals Pvt. Ltd. |
134-B-S-V. Co.Op. Industrial Estate,IDA, Bollaram(V), Jinnaram(M), Sangareddy (Dist) 505325, Telangana. India Telangana. |
Telangana |
27-04-2023 |
The Assay of Paracetamol dose not complies as per IP Specification, hence the sample is of NOT OF SANDARD QUALITY |
6 |
Fepanil-120 Suspension, Paracetamol Pediatric Oral Suspension |
FOH22J16 |
07/2022 |
12/2024 |
HI-TECH Pharmaceuticals Pvt. Ltd. |
134-B-S-V. Co.Op. Industrial Estate,IDA, Bollaram(V), Jinnaram(M), Sangareddy (Dist) 505325, Telangana. India Telangana. |
Telangana |
27-04-2023 |
The Assay of Paracetamol dose not complies as per IP Specification, hence the sample is of NOT OF SANDARD QUALITY |
7 |
BYTSOL Tablets, BETAMRTHASONE |
BTS-2205 |
08/2022 |
07/2024 |
Concord Drugs Ltd. |
Sy. No. 249, Brahmanapally, RR (DT), TS-501 511 Telangana. |
Telangana |
03-03-2023 |
Betamethasone, Manufacturer failed to indicate equivalency of Betamethasone sodium phosphate to Betamethasone on the product label. |
8 |
Pan-D Tablets, Pantoprazole Gastro-resistant Tablets IP |
22441755 |
06/2022. |
05/2025 |
Alkem Heath Science Aunit of Alkem Laboratories. |
Unit-2, Samardung, Karek Block, P.O. Namthang, South Sikkim - 737137, Sikkim. |
South Sikkim |
10-03-2023 |
Samples is of NOT OF STANDARD QUALITY with respect to Description and Assay of Pantoprazole and Domperidone. |
9 |
Pan-40 Tablets, Pantoprazole Gastro-resistant TabletsIP |
22442076 |
07/2022 |
12/2024 |
Alkem Heath Science Aunit of Alkem Laboratories. |
Unit - 2, Samardung, Karek Block, P.O. Namthang, South Sikkim - 737137, Sikkim. |
South Sikkim |
10-03-2023 |
The principal peak of sample solution does correspond with Principal peak of standard solution as per IP. Hence the sample is of NOT OF STANDARD QUALITY with respect to Identification, Assay and Dissolution test. (NIL DRUG). |
10 |
Glimepiride Tablets IP 2 mg |
GP04 |
04/2021 |
03/2023 |
Suzikem Drugs Pvt.Ltd. |
Plot No. 205/2A, IDA, Cherlapally, Phase-II, Medchal-Malkajgiri District, TS- 500 051. |
Telangana |
27-07-2022 |
The sample does not meet the Dissolution test as per IP specifications hence, it is of NOT OF STANDARD QUALITY. |
11 |
Thyronorm Tablets, Thyroxine Sodium Tablets I.P. |
AEG1987 |
03/2021 |
02/2023 |
Acme Generics LLP |
Plot No. 115, HPSIDC, Industrial Area, Davni, P.O. Gurumajra, Tehsil, Nalagarh, Dist. Solan, Himachal Pradesh - 174101, Goa Himachal Pradesh. |
Himachal Pradesh |
03-03-2022 |
Sample does not complies Identification and assay of Thyroxine sodium tablets I.P (Drug Nil) as per Indian Pharmacopoeia 2018. |
12 |
Tablets, Serratiopeptidase Tablets IP 10 mg |
BTSE-104 |
03/2021 |
02/2023 |
ANG Lifesciences India Ltd, |
Village Malkumara, Nalagarh Road, Baddi, Solan (H.P). Himachal Pradesh. |
Himachal Pradesh |
24-03-2022 |
As per I.P 2018 Disintegration test for Gastro resistant tablets should not show any cracks that would allow escape of contents of disintegration in 0.1 M Hcl when operated without discs for 120 min. Cracks were observed on all tablets tested. Hence Disintegration Test does not complies. |
13 |
Valtrax Others, Hydroxyzine Hydrochloride Oral Solution IP 10 mg |
RL2009-98 |
09/2020 |
08/2022 |
Regent Ajanta Biotech |
86-87, Village Makhiyali Dundi, Peerpura Road, Roorkee - 247667 (UK) Uttarakhand. |
Uttarakhand |
29-03-2022 |
Oral solution contains few visible suspended particles. Sample description does not complies as per IP. |
14 |
Santopod-200 Tablets, Cefpodoxime Proxetil Tablets IP. |
MMT-1508 |
04/2021 |
03/2023 |
MAYOFORD PHARMA |
Near Railwary Crossing, Chambaghat, Solan, Distt. Solan - 173 212, Himachal Praddesh. |
Himachal Praddesh |
28-02-2022 |
Dissolution test does not complies as per IP 2018. |
15 |
Metney 400 Tablets, Metronidazole Tablets IP 400 mg |
B.No. CN2101 |
05/2021 |
04/2023 |
Century Drugs Private Limited |
Pot No. 38, Sector 3 Pithampur, Dist. Dhar.. |
M.P. |
22-02-2022 |
Dissolution test does not complies as per IP specifications, hence the sample is of NOT OF STANDARD QUALITY. |
16 |
Thyronorm 100mcg Tablets, Thyroxine Sodium Tablets IP. |
AEG1233 |
04/2021 |
03/2023 |
ACME Generics LLP |
Plot No. 115, HPSIDC, Industrial Area, Davni, P.O. Gurumajra, Tehsil, Nalagarh, Solan, Himachal Pradesh - 174101, India, Himachal Pradesh . |
Himachal Pradesh . |
|
1. On the bottle it is written as 100 mcg but in the composition it is mentioned as Thyroxine Sodium 50 mcg. And also the tablets has monogram as 100 on one side. It is a misbranded samples. 2. Assay for Thyroxine sodium as per IP is NIL. |
17 |
Aetodol-P Tablets, Etodolac & Paracetamol Tablets |
T21.03 |
01/2021 |
12/2022 |
Oaksun Lifesciences |
Plot No. 36,37,38,46&47, Chengicherla, Medipally, Medchal, Malkajgiri, T.S Telangana |
Telangana |
08-12-2021 |
The Disintegration test does not meet the specification limits as mentioned in IP for film coated tablets. Out of 18 tablets, 12 tablets did not disintegrate within 30 minutes. Limit: Out of 18 tablets, only 2 tablets are permissible. |
18 |
Para 650 Tablets, Paracetamol Tablets IP 650 mg |
B 504 |
06/2021 |
05/2024 |
A-Klass Drugs & Pharmaceuticals Pvt.Ltd, |
D-48, M.I.D.C., Khamgaon - 444 303. Dist. Buldana (M.S) Maharashtra |
Maharashtra |
08-12-2021. |
Sample does not complies Assay and Dissolution parameters as per PARACETAMOL TABLETS I.P. 2018 |
19 |
Suspension, NEPAFENAC OPHTHALMIC SUSPENSION 0.1% W/V |
OP466B |
03/2021 |
02/2023 |
Pace Biotech |
Surajpur, Paonta sahib, Distt Sirmour (H.P) - 173 001 Himachal Pradesh |
Himachal Pradesh |
10-12-2021 |
As per Indian Pharmacopoeia 2018, Eye Drops are STERILE solutions or suspensions. Nepafenac Opthalmic Suspension does not complies TEST FOR STERILITY as per I.P 2018 |
20 |
Nepalet Ophthalmic solutions, Nepafenac Opthalmic suspension |
OP466B |
03/2021 |
02/2023 |
Pace Biotech |
Surajpur, Paonta sahib, Dist Sirmour (HP) 173 001 Himachal Pradesh |
Himachal Pradesh |
10-12-2021 |
As per Indian Pharmacopoia 2018, Eye Drops are STERILE solution or Suspensions. Nepafenac Opthalmic suspension does not complies TEST FOR STERILITY as per I.P. 2018 |
21 |
Deca Durabolin 50 Injection/Nandrolone Decanoate Injection IP 50mg/ml |
G001965 |
04/2020 |
01/2024 |
Zydus Healthcare Ltd |
Manufactured at Plot No. 203-213, Kundaim Industrial Estate, Kondaim, Goa - 403115 |
Goa |
09-11-2021 |
The assay of Nandralone Decanoate fails to fall within the I.P.limits and hence does not comply as per I.P. Nandrolone decanoate Injection IP 50mg Mentioned on outer laber while Nandrolone decanoate Injection IP 25mg mentioned over the label on the injection vial |
22 |
Acedecc Plus Tablets, Aceclofenac & Paracetamol |
DT-19135 |
03/2020 |
02/2022 |
Deccan Healthcare Limited |
Plot No.13, Sec-3, Sidcul, IE, Pantnagar, U.S. Nagar - 263153.Uttarakahand |
Uttarakahand |
18-09-2021 |
The assay of Paracetamol and Aceclofenac are not within the prescribed limits |
23 |
Cefico100/Cefixime Dispersible Tablets IP |
PBT-0605B |
06/2021 |
05/2023 |
Pacific India |
Village Dhana (Bagh Bania) Nalgarh, Dist Solan (H.P). |
Himachal Pradesh |
14-09-2021 |
As per I.P. Dispersible Tablets should disintegrate with in 3 min. Out of 12 tables tested 10 tablets not Disintegrated. Ref: Cefixime Dispersible Tablets IP in I.P.-2018 |
24 |
Linezolid Tablets IP 600 mg |
LIN2004 |
11/2020 |
10/2022 |
Life line Pharma |
188/1 Iyyanar Koli Road, Mettupalayam, Puducherry - 605 009. |
Puducherry |
12-07-2021 |
The sample does not complies for DISSOLUTION as per IP |
25 |
PAPERIN SUSPENSION (Paracetamol & Chlorpheniramine Maleate suspension) |
PAP190801 |
08/2019 |
07/2021 |
Aditus Laboratories Limited |
Plot No. - 22, Phase I, IDA, Cherlapally, Hyderabad - 500 051. |
Telangana |
09-02-2021 |
"Sample does not comply for the Assay of Paracetamol as per manufacturers standard testing procedure." |
26 |
Telmisartan Tablets IP |
TL08 |
05/2020 |
04/2022 |
M/s. Suzikem Drugs Pvt.Ltd. |
M/s. Suzikem Drugs Pvt.Ltd, Plot No. 205/2A, Cherlapally, Phase II , Medchal- Malkajgiri - 500051. |
Telangana |
18/01/2021 |
sample does not comply for the Dissolution test through all the three stages ie. S1,S2&S3 as per I.P." |
27 |
PF-650,(Paracetamol tablets I.P) |
T-200735 |
07/2020 |
06/2022 |
M/s. Villin Bio Med Ltd., |
M/s. Villin Bio Med Ltd., Unit II (AN ISO 9001:2008 & GMP Cretified Co.) Khasra No. 85, Madhopur Hazarathpur, Roorkee-247667, Uttarakhand. |
Uttarakhand |
28-01-2021 |
Does Not Complies Dissolution test of Paracetamol tablets I.P 2018 |
28 |
Pantorazole Tablets IP |
PP12 |
04/2020 |
11/2021 |
M/s. Suzikem Drugs Pvt.Ltd, |
M/s. Suzikem Drugs Pvt.Ltd, 205/2A,IDA,Phase-II,Cherlapally, Medchal-Malkajgiri -500051 |
Telangana |
07-01-2021 |
Does not Complies Dissolution Test of Pantorazole Tablets IP2018 |
29 |
PANMARK 40 |
|
|
|
|
|
|
|
|
30 |
Enalapril Maleate Tablets IP 5 mg (Brand Name: Lapril-5) |
GA20023 |
12/2020 |
11/2022 |
M/s Ortin Laboratories Ltd. |
Plot No. 275, 278 (Part), IDA Pashamylaram, Patancheru Mandal, Sangareddy Dist., Telangana State |
Telangana |
26-02-2022 |
The sample does not comply with the I.P. specifications regarding test parameters Assay and Dissolution. |
31 |
Enalapril Maleate Tablets IP 2.5 mg (Brand Name: Lapril) |
GB21079 |
08/2021 |
07/2023 |
M/s Ortin Laboratories Ltd. |
Plot No. 275, 278 (Part), IDA Pashamylaram, Patancheru Mandal, Sangareddy Dist., Telangana State |
Telangana |
18-02-2022 |
The sample does not comply with the I.P. specifications regarding test parameters Assay and Dissolution. |
32 |
RAZOVIN-20 |
IRVT1901 |
05/2019 |
04/2021 |
Seldom Pharma Pvt.Ltd., |
# 6-8-122, UT of Puducherry - 533464. |
Puducherry |
05-02-2020 |
Sample does not comply for Dissolution test (Acid phase) as per Rabeprazole Sodium Tablets I.P. monograph 2018. |
33 |
MONTYNOVA-LC SYRUP (Levocetrizine Hydrochloride and Montelukast Sodium Syrup) |
B.No. CDL095 |
09/2018 |
08/2020 |
Concord Drugs Ltd. |
Survey No. 249, Brahmanapally (V), R.R. Dist, Telangana State-501 511 |
Telangana |
19-06-2019 |
It is observed that the sample is NOT CLEAR AND CONTAINS WHITE CRYSTALS. |
34 |
Pan-Pra-40 |
PPT.10318 |
03/2019 |
02/2021 |
Cartel Laboratories |
Plot No. 10/A and 11/A, Chengicherla, Medchal - Malkajgiri Dist, Telangana State |
Telangana |
08-01-2020 |
Dissolution test does not complies as per IP |
35 |
Pantodex(Pantoprazole Gastroresistant Tablets I.P) |
IPFT-007 |
09/2018 |
08/2020 |
Mfd India by: Laborate Pharmaceuticals India Ltd |
(Unit-II), 31, Rajban road, Nariwala, Paonta Sahib (H.P). |
Himachal Pradesh |
02-12-2019 |
The sample does not meet the dissolution test as per IP Specification and hence it is of Not of Standard Quality. |
36 |
JASPAN-40 Tablets(Pantoprazole Tablets I.P) |
JJMT-18442 |
10/2018 |
09/2020 |
Mfd.by: JMM Laboratories |
Khari, Kala Amb Tehsil: Nahan, Sirmour H.P., |
Himachal Pradesh |
04-12-2019 |
The sample does not meet the dissolution test as per IP Specification and hence it is of Not of Standard Quality. |
37 |
Albendazole Tablets 400 mg I.P. |
ABZ19006 |
07/2019 |
06/2021 |
Mfd.by: Indian Drugs and Pharmaceuticals Ltd., |
11-5-297, 298, Balanagar, Medchal - Malkajgiri,Telangana |
Telangana |
03-12-2019 |
The sample does not meet the dissolution test as per IP Specification and hence it is of Not of Standard Quality |
38 |
Albendazole Tablets 400 mg I.P. |
ABZ19005 |
07/2019 |
06/2021 |
Indian Drugs and Pharmaceuticals Ltd. |
11-5-297 298, Balanagar, Medchal - Malkajgiri, Hyderabad - 500 055, Telangana |
Telangana |
02-12-2019 |
Dissolution test does not complies as per IP. |
39 |
Albendazole Tablets 400 mg I.P |
ABZ19007 |
07/2019 |
06/2021 |
M/s. Indian Drugs and Pharmaceuticals Ltd. |
D.NO. 11-5-297 298, Balanagar, Medchal - Malkajgiri, Hyderabad-500055, Telangana |
Telangana |
02-12-2019 |
Dissolution test does not complies as per IP. |
40 |
Albendazole Tablets 400 mg IP |
ABZ19010 |
08/2019 |
07/2021 |
M/s. Indian Drugs and Pharmaceuticals Ltd. |
D.No. 11-5-297 298, Balanagar, Medchal-Malkajgiri District - 500037. Telangana |
Telangana |
29-11-2019 |
Sample does not comply for the Dissolution test as per Albendazole Tablets I.P. 2018 monograph |
41 |
Levosalbutamol Sulphate, Ambroxol Hydrochloride Guaiphenesin Syrup (BRODIL) |
190601 |
06/2019 |
05/2021 |
Reino Remedies Pvt.Ltd. |
B1, B2, B3/20, G.I.D.C., Sector-25 Gandhi Nagar, Gujarat. |
Gujarat |
15-11-2019 |
As per Indian Pharmacopoeia Syrups described under the category of Oral Liquids, Oral liquids are HOMOGENOUS liquid preparatuions. This syrup (Brodil) is Not Homogenous and contains white crystals visible to naked eye and also contains white crystal sediment at botton. The sample does not complies for Description of Syrups (Oral liquids) as per Indian Pharmacopoeia 2018. |
42 |
Albendazole Tablets 400 mg IP |
ABZ19008 |
07/2019 |
06/2021 |
M/s. Indian Drugs and Pharmaceuticals Ltd. |
D.No. 11-5-297 298, Balanagar, Medchal-Malkajgiri District - 500037. Telangana |
Telangana |
02-12-2019 |
The sample does not complies for Dissolution test as per Albendazole Tablets I.P. monograph 2018. |
43 |
Panzo 40 Tablets (Pantaprazole Gastro Resistant Tablets) |
GPSD-651 |
02/2019 |
07/2021 |
Greenpark Bio-sciences |
Adavipolam, Hamlet of Yanam, U.T. of Puducherry - 533 464. |
Pondicherry |
18-11-2019 |
The sample does not complies for Dissolution as per IP. |
44 |
Clavocil-375 (Amoxycillin Potassium Clavulanate tablets IP) |
BT0560E |
04/2019 |
03/2021 |
M/s. J.M. Laboratories |
Village-Bhanat, P.O.-Ghatti, Subathu Road, Solan (H.P). 173211. |
Himachal Pradesh |
26-10-2019 |
Sample fails to meet the requirements of description, assay and dissolution tests stated in Amoxycillin Potassium Clavulanate tablets monograph as per I.P 2018 |
45 |
Vitamin B-Complex Tablets NFI |
0087 |
01/2019 |
06/2020 |
Stride Organics Pvt.Ltd. |
Sy.No. 265/p, Kondapur (Vil), Ghatkesar, Medchal Dist. (T.S). |
Telangana |
15-10-2019 |
The sample does not complies for Description of Tablets as per Indian Pharmacopoeia 2018. |
46 |
DEFLAROID-6 Deflazacort Tablets |
SM9094 |
07/2019 |
06/2021 |
M/s. Samson Laboratories Pvt.Ltd. |
152, Sansiwala, Barotiwala, Dist. Solan, (H.P)-174103. |
Himachal Pradesh |
03-10-2019 |
The sample does not complies for Assay of Deflazacort Tablets as per Standard testing procedure. |
47 |
FLEXON Suspension |
D703G148 |
07/2018 |
06/2021 |
M/s. Aristo Pharmaceuticals Pvt.Ltd. |
Survery No. 371, Kunbar Falia, Village: Dabhel, Nani Daman - 396 210, Daman (U.T). |
Diu and Daman |
30-10-2019 |
Orange coloured liquid was found to be minute crystals. The sample does not complies for DESCRIPTION as per IP. |
48 |
SKYWORM Tablets |
BST-1171 |
12/2018 |
11/2021 |
M/s. Bonn Schtering bio Sciences |
Plot No. 64 65, 1st floor, Electronic park, Thrubuvanai, Mannadipet, Commune, Puducherry - 605 107. |
Pondicherry |
11-10-2019 |
SAMPLE DOES NOT MEET THE DISINTEGRATION TEST AS PER IP: The test was conducted with 6 tablets, all the 6 tabets did not disintegrate within 15 minutes, so the test was repeated with 12 additional tablets, all the 18 tablets are not disintegrated within 15 minutes. Hence, the sample does not meet the IP Specification with respect to Disintegration test and manufacture method of Disintegration test. |
49 |
Diclofenac Sodium Injection IP |
1810 |
12/2018 |
12/2020 |
M/s. Arco Lifescience (I) Pvt.Ltd. |
C-86, M.I.D.C, Hingna, Nagpur-16. |
Maharashtra |
18-09-2019 |
Sample does not comply with the test for sterility as per I.P. 2018 specifications. |
50 |
Glycopyrrolate Injection USP |
I-15635 |
12/2017 |
11/2019 |
M/s. Jackson Laboratories Pvt.Ltd. |
22-24, Majitha Road, Bye Pass, Amritsar - 143001 |
Punjab |
17-09-2019 |
Sample does not comply with the test for sterility. |
51 |
Thiopental for Injection IP 500 mg |
17191 |
12/2017 |
11/2019 |
SWISS PARENTERALS LTD |
G.I.D.C, Nr. Bavla Dist. Ahmedabad - 382220 |
Gujarat |
17-09-2019 |
Sample does not comply with the test for sterility as per I.P. 2018 specifications. |
52 |
CIPROVIS - 250 |
FT-190226 |
02/2019 |
01/2021 |
M/s. Fizark Healthcare |
Khasra No. 192, 193, 194, 214, Salempur, Roorkee (U.K). |
Uttarakhand |
26-09-2019 |
Dissolution does not complies as per IP |
53 |
CF3-O 250 |
B-164 |
06/2018 |
05/2020 |
M/s. Care Well Health Care |
142, Maha Gujarat Industrial Estate, Moraiya, Serkhej-Bavla Road, Ahmedabad - 382210. |
Gujarat |
23-09-2019 |
Uniformity of weight does not complies as per IP. The test for Uniformity of weight was conducted with 20 tablets. Out of 20 tablets, 9 tablets deviated for + 5% percent limit and none of the tablets deviated for + 10% limit. Hence the sample does not meet the IP specification with respect to uniformity of weight. Limit: As per IP not more than two of the individual weights deviate from the average weight by more than the percentage (+ 5 percent) and none deviates by more than twice that percentage (+ 10 percent). |
54 |
Nilacid (Dried Aluminium Hydroxide Gel, Magnesium Hydroxide Semethicone Oral Suspension) |
NLC-50 |
07/2018 |
12/2019 |
M/s. Merino Laboratories Pvt.Ltd. |
5-35/A, Plot No. 8, First Floor, Prashanthi Naga, Kukatpally, Medchal - Malkhajgiri District - 500 072. |
Telangana |
09-05-2019 |
The sample does not complies for Assay content for Aluminium Oxide |
55 |
Eraflox-OX (Ofloxacin and Ornidazole Tablets I.P.) |
EFZ 10118 |
06/2018 |
05/2020 |
Cartel Laboratories |
Plot No. 10/A and 11/A, Chengicherla, Medchal - Malkajgiri Dist. Hyderabad. |
Telangana |
10-07-2019 |
Sample fails to meet the requirements of dissolution test at all the tree stages (S1,S2 and S3) as per the monograph, Ofloxacin and Ornidazole tablets I.P. 2018 |
56 |
PANOUS 40 TAB |
ST-551 |
01/2019 |
12/2020 |
M/s. Sridhara Life Sciences Pvt.Ltd. |
Khasra No. 285, Sisona, Bhagwanpur, Roorkee, Dist. Haridwar, (U.K.) |
Uttarakhand |
12-07-2019 |
Dissolution does not complies as per IP. |
57 |
Bayi Ki Dhava Tablets (Seized spurious Drug) |
Nil |
Nil |
Nil |
Nil |
Nil |
Nil |
12-06-2019 |
Spurious Drug |
58 |
ROBEEZ DSR CAPSULES (Rabeprazole sodium and Domperidone sustained release capsules) |
KF17192 |
09/2017 |
08/2019 |
Krish Care Formulations |
11-6-56/2/25, Opp. IDPL Factory, Balanagar-500037. |
Telangana |
23-05-2019 |
Sample fails in the assay of Rabeprazole sodium i.e does not meet the Labeled content as per standards for Patent and Proprietary Medicines in Schedule-V of Drugs and Cosmetics Act, 1940 and Rules. |
59 |
Lignocaine Hydrochloride Injection IP 30 mL |
I-15280 |
10/2017 |
09/2019 |
M/s. Jackson Laboratories Pvt.Ltd. |
22-24, Majitha Road, Bye Pass, Amritsar-143001 |
Punjab |
03-05-2019 |
Sample does not comply with the monograph of Lignocaine Injection IP for the description, test for particulate matter as per I.P. 2014 volume-I Pg.No. 2099, 956 respectively |
60 |
Oxytetracycline Hydrochloide Injection IP Vet. |
VT-2203 |
09/2018 |
08/2020 |
M/s. Alpha Laboratories Ltd. |
A.B. Road, Pigdamber-453446, Indore (M.P). |
Madhya Pradesh |
03-05-2019 |
Sample does not comply with the monograph of Oxytetracycline Hydrochloide Injection IP for the description, test for particulate matter as per I.P. 2018 volume-I Pg.No. 2824, 1114 respectively |
61 |
Pregalmin (Pregabalin and Methylcobalaine Capsules) |
DCAE11217 |
12/2017 |
11/2019 |
M/s. Suraksha Pharma |
410, Karondi, Roorkee- 247667, Uttarakhand. |
Uttarakhand |
16-05-2019 |
The Label claim of the Pregalmin sample (Pregabalin 75 gm ) is false/misleading the actual content of pregabalin found (76.69mg). Hence the sample declared as MISBRANDED. |
62 |
Pregalmin Capsules |
DCJ90618 |
06/2018 |
05/2020 |
M/s. Suraksha Pharma |
410, Karondi, Roorkee - 247 667, Uttarakhand. |
Uttarakhand |
01-05-2019 |
The sample does not complies for assay of Pregabalin as per IP. |
63 |
Pregalmin (Pregabalin and Methylcobalaine Capsules) |
DCJ90618 |
06/2018 |
05/2020 |
M/s Suraksha Pharma |
410, Karondi, Roorkee - 247 667, Uttarakhand. |
Uttarakhand |
09-05-2019 |
Sample did not meet the label content of pregabalin with respect to assay. |
64 |
Gentamincin eye/ear drops (GENTAPEN) |
EGN-0192 |
11/2017 |
10/2019 |
M/s E.G Pharmaceuticals |
Village Mandhala, Tehsil kasauli, Distt Solan, (H.P.) |
Himachal Pradesh |
01-05-2019 |
Sample does not comply with the general monograph of Eye/Opthalmic Drops, Ear/Otic Drops; Otic Solutions for the description as per I.P. 2014 volume -I Pg.No.932-933 |
65 |
Gentamincin eye/ear drops (Gracin) |
BC-2082 |
09/2017 |
08/2019 |
M/s. E.G Pharmaceuticals |
Village Mandhala, Tehsil kasauli, Distt Solan, (H.P.) |
Himachal Pradesh |
01-05-2019 |
Sample does not comply with the general monograph of Eye/Opthalmic Drops Ear/Otic Drops; Otic Solutions for the description as per I.P. 2014 vol-I Pg.No.932-933 |
66 |
Gentamincin eye/ear drops (GENTAPEN) |
EGN-0195 |
11/2017 |
10/2019 |
E.G Pharmaceuticals |
Village Mandhala, Tehsil kasauli, Distt Solan, (H.P.). |
Himachal Pradesh |
01-05-2019 |
Sample does not comply with the general monograph of Eye/Opthalmic Drops & Ear/Otic Drops; Otic Solutions for the description as per I.P. 2014 volume-I Pg.No.932-933 |
67 |
Gentamincin eye/ear drops Gracin |
BC 2082 |
09/2017 |
08/2019 |
M/s E.G Pharmaceuticals |
Village Mandhala, Tehsil kasauli, Distt Solan, (H.P.). |
Himachal Pradesh |
01-05-2019 |
Sample does not comply with the general monograph of Eye/Opthalmic Drops & Ear/Otic Drops; Otic Solutions for the description as per I.P. 2014 volume-I Pg.No.932-933 |
68 |
NIFY-CV 325 Tablets |
THMNC 7002 |
12/2017 |
05/2019 |
M/s. Finecure Pharmaceuticals Ltd. |
Shimla pistaur, Kichha, Udhamsing Nagar - 263 148. |
Uttarakhand |
29-04-2019 |
The sample does not complies for Assay fo Potassium Clavulanate as per IP. |
69 |
Excef-O Tablets (Cefixime and Ofloxacin Tablets) |
NWECO-1801 |
01/2018 |
12/2019 |
M/s. Konis Pharmaceuticals Pvt.Ltd. |
Jagriti Sadan, Subathu Road, Solan. |
Himachal Pradesh |
13-03-2019 |
The sample does not complies Disintegration test of Tablets as per I.P. |
70 |
Salbutamol Syrup IP 2mg/5mL |
TSM-17091 |
10/2017 |
09/2019 |
M/s. Maxchem Pharmaceuticals (P) Ltd. |
Plot NO.22, Sec-3, IIE, Pantnagar, Rudrapur, Dist, US Nagar - 263 153. |
Uttarakhand |
22-01-2019 |
Orange coloured syrup contains white insoluble suspended matter" hence sample did not meet the IP specification with respect to Description. |
71 |
Zetlog-150 (Rantidine Hydrochloride Tablets) |
T-7926 |
10/2017 |
9/2019 |
Gopish Pharm Ltd |
Ropar Road, Near Dherowal Barrier, Village Behrampur, Tehsil Nalagar, Solan. |
Himachal Pradesh |
22-01-2019 |
Assy found is less than IP limits 90-110% of 150mg, i.e 135mg-165mg. Hence the sample does not meet the Assay acceptance criteria. |
72 |
Tiniba 500 (Tinidazole Tablets IP) |
S705648 |
12/2017 |
11/2021 |
M/s. Zydus Health Care Ltd. |
NH.No.10, Majhitar, Rango, East Sikkim - 737 136. |
Sikkim |
15-12-2018 |
The sample does not pass the Disintegration test of Tinidazole Tablets I.P. |
73 |
T-98 Suspension (Paracetamol Paediatric Oral Suspension IP) |
BOBSQ026 |
08/2017 |
07/2019 |
Vilin Biomed Ltd |
Unit-II Khasra NO. 85, Madhopur, Hazarathpur, Roorkee-247667 Uttarakhand. |
Uttarakhand |
15-12-2018 |
The sample does not pass the test: 1. Description: Pink color suspension having transparent crystals of different shapes and sizes, suspension is not homogenous. 2. Assay of Paracetamol / 5 ml is less than the prescribed I.P limit and content of Paracetamol found to be 97.11 mg (i.e 77.68 percent) against 125 mg/ 5 ml label claim. |
74 |
HICEF-XL Tablets |
RST-407 |
01/2018 |
12/2019 |
Vilin Biomed Ltd. |
Unit-II Khasra No. 85, Madhopur, Hazarathpur, Roorkee-247667 Uttarakhand. |
Uttarakhand |
20-12-2018 |
The sample does not complies for Assay of Dicloxacillin as per IP |
75 |
Peptozip-D Tablets (Pantaprazole and Domperidone Tablets) |
AT-1801 |
01/2018 |
12/2019 |
India Pencillins Ltd. |
Plot No. 47 Chaitanyapuri, Hyderabad - 500 060 |
Telangana |
20-12-2018 |
The sample does not complies for Disintegration Test as per IP. |
76 |
RabiMak (Rabeprazole Sodium Tablets IP) |
KF18088 |
05/2018 |
04/2020 |
M/s. Krishcare Formulations |
11-6-56/2/25, Opp. IDPL Factory, Balanagar - 500 037. |
Telangana |
20-11-2018 |
Does not complies test for Dissolution (Buffer medium) of Rabeprazole Sodium Tablets I.P. 2014. |
77 |
RABIKOP- 20 Tablets (Rabeprazole Gastro-Resistant Tablets IP) |
QPT18-829 |
03/2018 |
02/2020 |
M/s. Qurx Pharmaceuticals |
Plot No. 191,191-A, Indl. Area, Phase-III, Sansarpur Terrace Dist. Kangra (H.P) - 176501 |
Himachal Pradesh |
12-11-2018 |
The sample does not complies for Description and Dissolution as per IP |
78 |
Paracet-500 (Paracetamol Tablets IP) |
PCT171006 |
10/2017 |
09/2019 |
M/s. Aditus Laboratories Limited |
22, Phase-1, IDA, Cherlapally, Hyderabad. |
Telangana |
27-11-2018 |
The sample does not complies for Dissolution Test as per IP. Hence the sample is of Not of Standard Quality with respect to Dissolution test for Paracetamol tablets. |
79 |
Procin |
PT 1814 |
05/2018 |
04/2020 |
Danish Health Care(P) Ltd. |
Industrial Estate. Maxi Road, Ujjain 456 010. |
Madya Pradesh |
22-11-2018 |
The sample does not complies for Dissolution Test as per IP. Hence the sample is of Not of Standard Quality with respect to Dissolution test for Paracetamol tablets. |
80 |
Paracetamol Tablets IP 500mg |
PTTV-35 |
01/2018 |
12/2020 |
M/s. Nestor Pharmaceuticals Ltd. |
11, W.E.A, Faridabad - 121 001 |
Haryana |
01-10-2018 |
Does not complies for Dissolution test. |
81 |
Co-Trimoxazole tablets I.P Double Stength |
TSM -17076 |
10/2017 |
09/2019 |
Maxchem Pharmaceuticals (P) Ltd. |
Plot No.22, Sec-3 IIE Panthnagar, Rudrapur, Distt. US Nagar - 263 153. |
Uttarakhand |
31-08-2018 |
Does Not Complies Disintegration test of tablets as per I.P. 2018. Out of 18 Tablets tested no tablets Disintegrated with in 15 minutes. Hence Disintegration test of tablets does not complies as per I.P |
82 |
Ferriwok-XT (Ferrous Ascorbate and Folic Acid Tablets) |
WIN1703 |
07/2017 |
06/2019 |
M/s. Innova Cap Tab |
81-B, EPIP, Phase - 1, Jharmajri, Baddi (H.P). |
Himachal Pradesh |
20-08-2018 |
Does Not Complies Uniformity of Weight of Tablets I.P. 2014. Out of 20 Tablets 2tablets Deviating Lower Limit and 3 Tablets Deviating Higher limit (5% deviation given to average weight). As per IP Not more than 2 of the individual weights deviate the limits. |
83 |
Pantomack-40 (Pantoprazole Tablets IP 40 mg Tablets) |
VT17-4349 |
12/2017 |
11/2019 |
M/s.Athens Life Sciences |
Mauza Rampur jattan, nahan road, Kala Amb, Distt. Sirmour, H.P. - 173 030. |
Himachal Pradesh |
31-08-2018 |
1. Does not Complies Dissolution of Pantoprazole Tablets I.P. 2014. 2. Assay of Pantoprazole Tablets I.P: Pantoprazole Tablets contain not less than 90 per cent (36mg) and not more than 110.0 per cent (44 mg) of the stated amount of pantoprazole. Sample contains less than 36 mg i.e 30.97 mg of Pantoprazole. Hence sample does not complies Assay of Pantoprazole Tablets I.P. |
84 |
Nucet Cold NF Tablets (Paracetamol, Phenylephrine Hydrochloride |
T-1704198 |
04/2017 |
03/2019 |
M/s. Aagya Biotech Pvt.Ltd. |
1.5Km., manglour-Saharanpur road, Manglour - 247 656, Roorkee Distt. Haridwar (U.K). |
Uttarakhand |
30-07-2018 |
The Assay content of Paracetamol does not complies as it is not within the limits of the label claim, Hence the sample is of Not of Standard Quality with respect to assay content of Paracetamol. |
85 |
MATOXY Injection I.P. (vet) |
MV7E16 |
05/2017 |
10/2018 |
M/s. Martin and Brown Bio-Sciences |
No.918/419, Malkumajra, Nalagarh Road, Baddi, Dist Solan, (H.P.) |
Himachal Pradesh |
20-07-2018 |
Sample fails to meet the general requirements of Parenteral preparations (Injections) for the description and particulate matter as per I.P. 2014 vol-I Pg.No. 956. |
86 |
Pomadol Plus (Tramadol with Paracetamol Tablets) |
AT-1801 |
02/2018 |
01/2020 |
M/s. India Pencillins Ltd. |
Plot No.47, Chaitanyapuri, Hyderabad - 500 060. |
Telangana |
17-07-2018 |
The Assay content of Tramadol Hcl, does not complies as it is not within the limits of the label claim. Hence the sample is of Not of Standard Quality with respect to assay content of Tramadol Hcl. |
87 |
NUKAST-4 yrup (Montelukast sodium 4mg Levocetirizine Hydrochloride 2.5mg Syrup) |
ZLACB17002 |
01/2017 |
12/2018 |
M/s.Zuventus Healthcare Ltd. |
C-12/13, M.I.D.C, Bhosari, Pune - 411 026. |
Maharashtra |
06-07-2018 |
Sample fails to meet the general requirements of oral liquids (syrup) of description as mentioned in I.P 2014 vol-I Pg.No.952. Sample fails in assay (Label claim) of Montelukast as per standards for Patent and Proprietary Medicines in Schedule-V of Drugs and Cosmetics Act, 1940 and Rules |
88 |
Pangerd-40 |
T-170644 |
06/2017 |
05/2019 |
M/s.Medrose Drugs & Pharmaceuticals |
51, Industrial Area, Phase-III, Sansarpur Terrace, Dist: Kangra, Pin - 176 501 (H.P). |
Telangana |
28-06-2018 |
The sample does not complies for Dissolution test as per IP |
89 |
Ketamine Hydrochloride Injection I.P |
I-15103 |
09/2017 |
08/2019 |
M/s.Jackson Laboratories Pvt.Ltd |
22-24, Majitha Road, Bye Pass, Amritsar - 143001 (India) |
Punjab |
23-06-2018 |
The sample does (Ketamine Hydrochloride Injection I.P.) does not comply with the test for sterility as per I.P. Stated under other tests for Parenteral preparations (Injections). |
90 |
Pantib-DSR Capsules |
SBC-1739 |
10/2017 |
09/2019 |
M/s. Sama Biotech |
Dol, Goljamala, Swarghat Road Nalagar, Solan (H.P.) - 174101. |
Himachal Pradesh |
21-06-2018 |
The Assay content of Pantoprazole does not complies as it is not within the limits of the label claim. Hence the sample is of Not of Standard Quality with respect to assay content of Pantoprazole. |
91 |
Kufen-Q tablets |
CRT17030 |
08/2017 |
07/2019 |
M/s.Cinchona Remedies |
Plot No.25, Balanagar, R.R. Dist (T.S)500037. |
Telangana |
18-06-2018 |
Sample Did not Meet the Description As per IP. Brown spots are observed on the tablets and they are extended inside the layer of tablets. Hence the sample did not meet the IP specifications with respect to Description test |
92 |
Dobutamine Hydrochloride Injection I.P. 250mg/20mL |
DB11709BC |
10/2017 |
09/2019 |
M/s. Celon Laboratories Pvt.Ltd. |
Plot No. 2, ALEAP Industrial Estate, Gajularamaram, Medchal District - 500 090. |
Telangana |
31-05-2018 |
The sample (Dobutamine Hydrochloride Injection I.P) does not meet the requirements of Parenteral Preparations (Injections) for the description and particulate matter as per I.P. |
93 |
CF3O 250 Tablets (Cefuroxime Tablets I.P.) |
T161169B |
11/2016 |
10/2018 |
Roseate Medicare |
Vill. Anji, Solan (H.P.)-173212. |
Himachal Pradesh |
17-05-2018 |
The sample does not comply for the Dissolution test of Cefuroxime tablets as per I.P. 2014. |
94 |
PAN-TLS Injection (Pantoprazole for Injection) |
PN921G |
09/2017 |
08/2019 |
PACE Biotech |
Surajpur, Paonta Sahib Dist-Sirmour (H.P.)-173001. |
Himachal Pradesh |
16-05-2018 |
The sample does not comply for the Sterility test of the reconstituted solution as per I.P. |
95 |
J COLD Tablets |
JMT-17227 |
09/2017 |
08/2019 |
M/s. JMM Laboratories |
village: Khari, Tehsil: Nahan, dist: Sirmour (H.P) 173030. |
Himachal Pradesh |
05-05-2018 |
Sample does not meet the Description as per IP. Yellowish Brown spots are observed on the tablets and they are extended deep inside the tablets. Hence the sample did not meet the IP specification with respect to Description. |
96 |
LEVOCET-D Tablets (Levocetrizine Dihydrochloride and Phenylephrine Hydrochloride Tablets) |
LE1609007 |
09/2016 |
08/2018 |
M/s. BRD MEDILABS |
(Unit - II 19-20, DIC Indl. Area, Baddi (H.P)-173 205. |
Himachal Pradesh |
20-04-2018 |
The sample does not complies for Uniformity of weight, Identification Test and Assay of Phenylephrine Hydrochloride as per IP. |
97 |
CO-TRIMOXAZOLE TABLETS I.P. (Double Strength) |
TSM-17064 |
09/2017 |
08/2019 |
Maxchem Pharmaceuticals (P) Ltd. |
Plot No.22, Sec-3, IIE Pantnagar, Rudrapur, US Nagar 263153. |
Uttarakhand |
18-04-2018 |
The sample fails to meet the disintegration test as all the 18 tablets tested, did not disintegrate within 15 minutes. Hence the sample is NOT OF STANDARD QUALITY with respect to disintegration test for uncoated tablets as per I.P. 2014. |
98 |
P-ZOLE-40 TABLETS (PANTOPRAZOLE TABLETS I.P.) |
ULT-12338 |
04/2017 |
03/2019 |
M/s. Ultratech Pharmaceuticals |
Vill. Tipra, P.O barotiwala, Dist. Solan (H.P). |
Himachal Pradesh |
20-02-2018 |
Does not complies Dissolution test of Pantoprazole Tablets I.P. 2014. |
99 |
Aciloc RD |
16062 |
06/2016 |
05/2018 |
Cadila Pharmaceuticals Ltd. |
1389, Dholka-387810 Dist: Ahmedabad |
Gujarat |
30-01-2018 |
The Sample does not complies for Assay of Omeprazole and Domperidone and Disintegration test. |
100 |
Pantop-D Capsules |
B378D116 |
04/2016 |
03/2018 |
Aristo Pharmaceuticals Pvt. Ltd |
Village-Maknumajra P.P.Bhud, Baddi, Dist. Solan (HP) 173205 |
Himachal Pradesh |
18-01-2018 |
The Sample does not complies for Identification test, Assay and of Domperidone as pe IP |
101 |
Ceftum Tablets |
NA386 |
08/2016 |
07/2018 |
Glaxosmithkline Pharmaceuticals Limited |
at Plot. No. 45 A&B, Anrich Industrial Estate, I. D. A. Bollaram, Medak District-502 325 |
Telangana |
12-01-2018 |
The Sample does not complies for Identification test, Assay and Dissolution of Cefuroxime Axetil as pe IP |
102 |
Ultracet Tablets Tramadol and Acetaminophen Tablets |
N548 |
01/2017 |
12/2018 |
Johnson & Johnson Private Limited |
L. B. S. Marg, Mulund(west), Mumbai 400 080 |
Maharashtra |
04-01-2018 |
The Sample does not complies for Assay and Dissolution of Acetaminophen ad Tramadol Hydrochloride as per USP |
103 |
Omez-DSR Capsules(Omeprazole and Domperidone cap) |
G160JA105 |
12/2016 |
08/2019 |
Acme Generics L.L.P. |
Plot No.115, HPSIDC, Industrial Area, Dannvi, P. O. Gurumajra, Tehsil, Nalagarh, Dist. Solan H. P. 174102 |
Himachal Pradesh |
18-01-2018 |
The Sample does not complies for Identification Test and Assay of Domperidone as per IP |
104 |
ULTRACET Tramadol and Paracetamol Tablets |
BNo N504 |
11/2016 |
10/2018 |
Johnson and Johnson Private Limited |
L. B. S. Marg, Mulund(West) Mumbai 400 080 |
Maharashtra |
29-12-2017 |
The sample does not Complies for Assay and Dissolution of Tramadol Hydrochloride as per USP |
105 |
Pantoprazole Tablets I.P. |
EMR-1051 |
09/2016 |
08/2018 |
Sun Pharma Laboratories Ltd. |
Plot No. 107-108, Namli Block, P.O. Ranipool, East Sikkim -737135 |
Sikkim |
14-12-2017 |
The sample does not complies for the Assay content and Dissolution Test in Acid stage as per IP. |
106 |
Pantoprazole Tablets I.P. |
161275T |
12/2016 |
11/2018 |
M/s: Sai Sarvaa Biotech Pvt. Ltd. |
Plot No. 8 and 9, Balaji Nagar, Pattanur, Auroville(Po), Vanur(Tk), Villapuram(Dt.)Pin 605 101 |
Tamil Nadu |
11-12-2017 |
The sample does not complies for the Dissolution Test in Acid stage as per IP. |
107 |
Unitac 150 Tablets (Ranitidine Hydrochloride Tablets IP) |
AT-657 |
01/2017 |
12/2018 |
Anrose Pharma |
147, Mauza Sansiwala, Post: Barotiwala, Tehsil: Kasauli, Dist. Solan, H.P. |
Himachal Pradesh |
07-10-2017 |
The sample does not complies for Description as per IP. Hence, the sample does not meet the Ip specifications with respect to Description. |
108 |
PANTOCID (Pantaprazole Tables) |
EMR-1051 |
09/2016 |
08/2019 |
M/s. Sun Pharma Laboratories Ltd. |
Plot No. 107-108, Namli Block, P.O, Ranopoot, East Sikkim-1737135. |
Sikkim |
22-11-2017 |
The sample does not complies for Assay, Dissolution Description as per IP. |
109 |
PANTODAC Tablets |
S602085 |
06/2016 |
08/2019 |
M/s. Zydus Health care |
N.H.No.31A, Majhitar, Rangpo, East Sikkim - 737132 |
Sikkim |
25-11-2017 |
The sample does not complies for Dissolution as per IP. |
110 |
ULTRACET Tablets |
N504 |
11/2016 |
10/2018 |
M/s. Johnson & Johnson Private Limited |
L.B.S. Marg, Mulund(West), -400 080. |
Maharashtra |
20-11-2017 |
The sample does not complies for Assay of Tramadol Hydrochloride and Dissolution as per U.S.P. |
111 |
PANTOCID (Pantaprazole Tablets) |
EMR-1051 |
09/2016 |
08/2019 |
M/s. Sun Pharma Laboratories Ltd. |
Plot No. 107-108, Namli Block, P.O, Ranopoot, east Sikkim-1737135. |
Sikkim |
16-11-2017 |
The sample does not complies for Assay, Dissolution, Description, as per IP. |
112 |
Pantodac (Pantoprazole Gastro-resistant tablets I.P.) |
ZHS1012 |
01/2016 |
12/2018 |
Zydus Healthcare |
Bhaghey Khola, N.H.No.31 A, Majhitar Rangpo, East Sikkim, 737 132. |
Sikkim |
27-11-2017 |
1. The sample does not comply Assay of Pantoprazole (64.97%) as per I.P. 2014 and 2. The sample does not comply Dissolution (at Buffer state) as per I.P. 2014. |
113 |
ULTRACET (Acetaminophen and Tramadol Hydrochloride Tablets USP), |
N504 |
11/2016 |
10/2018 |
Johnson & Johnson Private Limited |
L.B.S. Marg, Mulund (West), Mumbai-400 080. Mfd at. Encore Healthcare Pvt.Ltd., Plo No. D-5, M.I.D.C., Industrial area, Paithan, Aurangabad - 431 148. |
Maharashtra |
20-11-2017 |
1. The sample does not comply for the Identification and Assy of Tramadol hydrochloride (NIL drug), 2. The sample does not comply for the Assy of Acetaminophen (63.58%w/w) and 3. The sample does not comply for the Dissolution test as per U.S.P. |
114 |
Pantop-DSR (Enteric coated Pantoprazole and Domperidone SR Capsules) |
B452L056 |
11/2016 |
10/2018 |
ARISTO Pharmaceuticals Pvt.Ltd. |
Village: Makhnumajra, P.O. Bhud, Baddi, Dist. Solan (H.P.) |
Himachal Pradesh |
24-11-2017 |
1. The sample does not comply for the Identification and Assy of Pantoprazole (NIL drug) and 2. The sample does not comply for the Identification and Assy of Domperidone (NIL drug) as per S.T.P. 3. The sample composition on the strip states that it contains"Two Gastro resistant Pantoprazole tablets 20mg" (each) & Domperidone as " sustained release pellets" 30mg, but upon obsevation of capsules it was found to contain only white pellets and tablets were absent. |
115 |
Digeplex |
R16005128/14 |
12/2016 |
05/2018 |
M/s. Shreya Life Sciences Pvt.Ltd. |
13,14,15: Raipur, Po: Bhagwanpur, Roorke-247 661 Uttarakhand. |
Uttarakhand |
21-11-2017 |
The undissolved egg albumin Left in the assay of pepsin is not within the IP limits, hence the sample does not meet the IP specification with respect to assay of Pepsin. |
116 |
Valporate Chrono-300 |
VHB17002 |
03-2017 |
02-2019 |
M/s. Crescent Formulations Pvt. Ltd. |
Khasra No. 587/588, Beside Jharmajri Village: Kunjhal, Baddi, Tehsil: Nalagarh, Dist: Solan, HP 173205. |
Himachal Pradesh |
16-11-2017 |
While opening the tablets from the strip, the tablets are found to be wet and are not intact.
As per IP 2014 (Page :959) the tablets should be sufficiently hard to withstand handling, without crumbling or breaking. Hence the sample does not meet the IP Specifications with respect to description. |
117 |
(Telverge 40) Telmisartan Tablets I.P. 40 mg |
BLBP17016 |
01/2017 |
12/2018 |
Bioaltus Pharmaceuticals Pvt.Ltd. |
Village Saini Majra, Nalagarh - Ropar Road, Nalagarh, Dist. Solan |
Himachal Pradesh |
17-10-2017 |
The sample does not meet IP Specifications for Dissolution of Telmisartan Tablets IP. |
118 |
Pantoprazole Gastroresistant Tablets I.P. |
GPT-162523 |
11/2016 |
10/2018 |
Gnosis Pharmaceuticals Pvt.Ltd |
Nahan Road, Village: Moginanad, Kala-Amb, Disst. Sirmour - 173 030 (H.P). |
Himachal Pradesh |
12-10-2017 |
The sample does not complies for the Dissolution Test in Acid stage as per IP. |
119 |
Diflox 200 Tablets |
T-8595 |
10/2016 |
09/2018 |
M/s. PCD Health Care |
(Vil) Kunja, Paonata Sahib (Dist) Sirmour (HP), 173 025. |
Himachal Pradesh |
26-09-2017 |
A) Does not Complies Description of tablets as per I.P. 2014 B) Does not Complies Uniformity of weight of tablets as per I.P. 2014 C) Does not Complies Dissolution Test of Ofloxacin Tablets I.P. 2014 D) Does not Complies Assay of Ofloxacin Tablets as per I.P. 2014. |
120 |
Budesonide Nebuliser Suspension BP |
ABT1048 |
04/2017 |
03/2019 |
M/s Cadila Healthcare Limited |
Shree shyam singh nursery. Phase-II, Indl Area Bhiwandi, Mfg at SP-918, Phase-III, Indl Area, Bhiwandi Dist. Alwar 301019. |
Rajasthan |
21-09-2017 |
The sample does not comply the requirements of preparations for inhalation with respect to description as per BP monograph for inhaled products Ph Eur monograph 0671. |
121 |
Budesonide Nebuliser Suspension BP |
ABT1024 |
02/2017 |
01/2019 |
M/s Cadila Healthcare Limited |
Shree shyam singh nursery. Phase-II, Indl Area Bhiwandi, Mfg at SP-918, Phase-III, Indl Area, Bhiwandi Dist. Alwar 301019. |
Rajasthan |
21-09-2017 |
The sample does not comply the requirements of preparations for inhalation with respect to description as per BP monograph for inhaled products Ph eur monograph 0671. |
122 |
Ondansetron Injection IP |
OND-030 |
11/2016 |
10/2018 |
Radico Remedies |
123, Mandhala, Barotiwala, Dist. Solan (H.P.) - 174103. |
Himachal Pradesh |
11-09-2017 |
The Sample is does not complies the test for sterility as per I.P. |
123 |
Povirex-Lotion (Povidone-Iodine Lotion) |
GPOL-005 |
06/2016 |
05/2018 |
M/s.Laborate Pharmaceuticals India Ltd. |
(Unit-2), 31, Rajban Road, Nariwala, Paonta Sahib (H.P.) |
Himachal Pradesh |
09-09-2017 |
Assay content of Iodine does not complies for the IP limit specifications. |
124 |
Ranitidine Inj |
A087 |
10/2016 |
05/2018 |
M/s. Weismanna Health care Pvt.Ltd., A.P. |
Pernamitta, Ongole, Andhra Pradesh 523225 |
Andhra Pradesh |
04-09-2017 |
The sample does not comply for the test for sterility as per I.P. |
125 |
Pantoprazole Tablets I.P. |
TPTS16-022 |
11/2016 |
10/2018 |
M/s. Greenland Organics |
6-174-1, Industrial Area, Surampalli - 521 212. |
Andhra Pradesh |
31-08-2017 |
The Sample does not complies test for Dissolution of Pantoprazole tablets I.P. 2014. |
126 |
Compound Sodium Lactate Injection (I.P) 500 ml |
16PD166 |
08/2016 |
07/2018 |
Pentagon Labs Limited |
16C/16D, Industrial Area No. 1, A.B. Road, Dewas - 455 001(M.P). |
Madya Pradesh |
29-07-2017 |
The Sample is NOT OF STANDARD QUALITY with respect to Test for sterility as per IP 2014. |
127 |
PRALIDOXIME IODIDE INJECTION |
HLI540L |
11/2015 |
10/2017 |
M/s. Himalaya Meditek Pvt.Ltd. |
Plot NO. 35 & 36, Pharmacity, Selaqui Industrial Area, Dehradun - 248 197. |
Uttarakhand |
11-07-2017 |
The sample DOES NOT COMPLIES the test for PARTICULATE MATTER as per I.P. |
128 |
Amoxycillin and Potassium Clavulanate Tablets IP |
SACT1116272 |
11/2016 |
04/2018 |
M/s.Stride Organics Pvt.Ltd. |
Sy.No.265/P, Kondapur (Vill) Ghatkeshar, R.R. District Telangana State |
Telangana |
31-07-2017 |
Does not complies Description of tablets and Dissolution Test for Amoxycillin & Potassium Clavulanate Tablets IP as per I.P 2014. |
129 |
Cinaclo Plus (Aceclofenac and Paracetamol) |
CRT1686 |
12/2016 |
11/2018 |
M/s.Cinchona Remedies |
Plot No: 25, Balanagar, Medchal
District, Telangana. |
Telangana State |
11-07-2017 |
Uniformity of weight does not complies as per IP
The test for Uniformity of weight was conducted with 20 tablets. Out of 20 tablets, 10 tablets deviated for + 5 % limit and 5 tablets deviated for + 10 % limit. As per IP not more than two of the individual weights deviate from the average weight by more than the percentage (+ 5 %) and none deviates by more than twice that percentage (+ 10 %). Hence the
sample does not meet the IP specification with respect to uniformity of weight. |
130 |
BANTOP TABLETS ( Pantoprazole Tablets I.P. 40 mg) |
SBT-1601 |
10/2016 |
09/2018 |
M/s.Concord Drugs Ltd. |
Nalhera, Anantapur, Roorkee-247668(UK) |
Uttarakhand |
31-07-2017 |
Does not complies Dissolution Test for Pantoprazole Tablets I.P as per I.P 2014. |
131 |
Blisto – 2MF |
BPSG16149 |
12/2016 |
11/2018 |
M/s.Swiss Gaenies Life sciences |
21 – 23, Indl. Area, Mehatpul, Dist. Una, H.P. |
Himachal Pradesh |
11-07-2017 |
Uniformity of weight does not complies as per IP
The test for Uniformity of weight was conducted with 20 tablets. Out of 20 tablets, 5 tablets deviated for + 5 % limit and none deviated for + 10 % limit. As per IP not more than two of the individual weights deviate from the average weight by more than the percentage (+ 5 %) and none deviates by more than twice that percentage (+ 10 %). Hence the sample does not meet the IP specification with respect to uniformity of weight. |
132 |
CALLACT TABLETS |
T-2419 |
06/2016 |
05/2018 |
M/s Sarwal Laboratory |
Plot. No.: 50 Phase – 1, Indl. Area, Gwalthai, Distt.
Bilaspur, H. P. |
Himachal Pradesh |
06-07-2017 |
The sample does not meet the Disintegration test as per IP.
The test was conducted with 6 tablets .Out of 6 tablets, 5 tablets did not disintegrate within 15 minutes. So the test was repeated with 12 additional tablets. Out of 18 tablets, only 3 tablets disintegrated within 15 minutes. But as per IP not less than 16 of the total of 18 tablets tested disintegrate. Hence the sample does not meet the IP specifications with respect to disintegration test. |
133 |
Dicloplan tablets |
IGTB-16-3802 |
12/2016 |
11/2019 |
M/s IG Pharma limited, |
12.4 km,Meerut road, Roorkee, Haridwar Dist. |
Uttarakhand |
03-06-2017 |
The sample does not comply Disintegration test as per IP 2014 |
134 |
Diclofenac Sodium Injection I.P |
A113 |
02/2017 |
07/2018 |
M/s Weismanna healthcare pvt ltd |
IDA pernamitta, |
Andhra Pradesh |
03-06-2017 |
The sample does not comply the test for Particulate matter as per IP |
135 |
Gentamicin Injection IP |
Batch No. 032 |
07/2016 |
12/2017 |
M/s. Weismanna Healthcare Pvt. Ltd. |
IDA, Pernamitta |
Andhra Pradesh |
21-04-2017 |
Does not complies uniformity of weight and Assay for Gentamicin as per IP 2010. |
136 |
Gentamicin Injection I.P. |
B.No. 032 |
07/2016. |
12/2017. |
M/s.Weismanna Health care Pvt.Ltd., |
I.D.A, Pernamitta - 523 002. |
Andhra Pradesh |
17-04-2017. |
The sample is NOT OF STANDARD QUALITY with respect to Test for Sterility as per IP. |
137 |
Gentamicin Injection I.P |
032 |
07/2016 |
12/2017 |
Weismanna Health care Pvt.Ltd. |
I.D.A, Pernamitta - 523 002. |
Andhra Pradesh |
21-04-2017 |
The sample is NOT OF STANDARD QUALITY with respect to Test for Sterility as per IP |
138 |
Gentamicin Injection I.P. |
032 |
07/2016 |
12/2017. |
Weismanna Health care Pvt.Ltd. |
I.D.A, Pernamitta - 523 002. |
Andhra Pradesh |
17-04-2017 |
The sample is NOT OF STANDARD QUALITY with respect to Test for Sterility as per IP. |
139 |
Compound Sodium Lactate Injection I.P., |
16386 |
03/2016 |
02/2018 |
M/s. Haseeb Pharmaceuticals Pvt.Ltd. |
Plot No. F-9/15 MIDC, Nagpur – 440 016. |
Maharashtra |
28-07-2016 |
The sample does not complies the test for Sterility as per IP. Note: Label not as per IP. (Sodium Hydroxide IP 0.114gm not mentioned in IP formulation). |
140 |
Compound Sodium Lactate Injection I.P., |
16382 |
03/2016 |
02/2018 |
M/s. Haseeb Pharmaceuticals Pvt.Ltd. |
Plot No. F-9/15 MIDC, Nagpur – 440 016. |
Maharashtra |
28-07-2016 |
The sample does not complies the test for Sterility as per IP. Note: Label not as per IP. (Sodium Hydroxide IP 0.114gm not mentioned in IP formulation). |
141 |
Compound Sodium Lactate Injection I.P., |
16381 |
03/2016 |
02/2018 |
M/s. Haseeb Pharmaceuticals Pvt.Ltd. |
Plot No. F-9/15 MIDC, Nagpur – 440 016. |
Maharashtra |
28-07-2016 |
The sample does not complies the test for Sterility as per IP. Note: Label not as per IP. (Sodium Hydroxide IP 0.114gm not mentioned in IP formulation). |
142 |
Compound Sodium Lactate Injection I.P., |
16383 |
03/2016 |
02/2018 |
M/s. Haseeb Pharmaceuticals Pvt.Ltd. |
Plot No. F-9/15 MIDC, Nagpur – 440 016. |
Maharashtra |
28-07-2016 |
The sample does not complies the test for Sterility as per IP. Note: Label not as per IP. (Sodium Hydroxide IP 0.114gm not mentioned in IP formulation). |
143 |
MEZOLAM, |
V304109 |
06/2015 |
12/2016 |
M/s. VHB Medi sciences limited, |
Plot No. 20-22&49-51, IIE, Sector - 5 SIDUCL, Pantnagar - 263145, Uttarakand, India |
Uttarakhand |
23-07-2016 |
The sample does not meet the test for sterility as per as per I.P. |
144 |
Povidone Iodine solution I.P. |
15B97 |
02/2015 |
01/2017 |
M/s. Relief – Lab P. Ltd., |
B/45, M.I.D.C Kalmeshwar – 441501.Maharastra Labelled as T.S. Govt Supply. Not for sale. |
Maharashtra |
05-08-16. |
The sample does not meet the Assay content for available Iodine as per IP Specifications. |
145 |
Povidone Iodine solution I.P. |
15B96 |
02/2015 |
02/2017 |
M/s.Relief – Lab P. Ltd., |
B/45, M.I.D.C Kalmeshwar – 441501.Maharastra Labelled as T.S. Govt Supply. Not for sale. |
Maharashtra |
05-08-16. |
The sample does not meet the Assay content for available Iodine as per IP Specifications. |
146 |
Povidone Iodine solution I.P. |
15B84 |
02/2015 |
01/2016 |
M/s.Relief – Lab P. Ltd., B/45, |
M.I.D.C Kalmeshwar – 441501.Maharastra Labelled as T.S. Govt Supply. Not for sale. |
Maharashtra |
05-08-2016. |
The sample does not meet the Assay content for available Iodine as per IP Specifications. |
147 |
Compound Sodium Lactate Injection I.P. |
16658 |
06/2016 |
05/2018 |
M/s. Haseeb Pharmaceuticals Pvt.Ltd. |
Plot No. F-9/15 MIDC, Nagpur – 440 016. |
Maharashtra |
20-08-16. |
The sample does not complies the test for Sterility as per IP. |
148 |
THIOPENTONE SODIUM INJECTION IP, |
N-4793 |
02/2015 |
01/2016 |
M/s. Kwality Pharmaceuticals Pvt.Ltd., |
Nag Kalan, Majitha Road, Amritsar, India. |
Punjab |
26-08-2016. |
The sample does not complies the test for Sterility as per IP. |
149 |
Compound Sodium Lactate Injection I.P. |
16529 |
05/2016 |
04/2018 |
M/s. Haseeb Pharmaceuticals Pvt.Ltd. |
Plot No. F-9/15 MIDC, Nagpur – 440 016. |
Maharashtra |
31-08-2016. |
The sample does not complies the test for Sterility as per IP. |
150 |
Compound sodium Lactate Injection I.P. |
1651 |
05/2016 |
04/2018 |
M/s. Haseeb Pharmaceuticals Pvt.Ltd., |
Plot No.F-9/15 MIDC, Nagpur - 440 016. |
Maharashtra |
02-09-2016. |
The sample does not complies the test for Sterility as per IP. |
151 |
Thiopentone Sodium Injection I.P. (for I.V. use) |
N-5719 |
08/2015 |
07/2017 |
M/s. Kwality Phamaceuticals Pvt.Ltd., |
Nagkalan, Majitha Road, Amritsar- India. Indication T.S. Govt. supply not for sale physical Stock 45x0.5gm. |
Punjab |
27-10-2016. |
The sample does not complies with the requirements for clarity of solution stated under Parenteral Preparations as per IP and also does not complies the test for Sterility as per IP |
152 |
Zettac Tablets (Ranitidine Hydrochloride Tablets IP), |
ZTC-1605 |
04/2015 |
03/2018 |
M/s. Concord Drugs Ltd., |
Nalhera Anantpur, Roorkee - 247 668 (A.P). |
Andhra Pradesh |
20-10-2016. |
The sample does not complies for Description as per IP. Irregular Spots observed on the coating surface of the tablet, Hecnce the sample does not meet the IP specifications with respect to Description. |
153 |
Thiopentone Sodium Inj. I.P. |
N-5719 |
08/2015 |
07/2017 |
M/s. Kwality Phamaceuticals Pvt.Ltd., |
Nagkalan, Majitha Road, Amritsar- India. |
Punjab |
06-10-2016. |
The sample does not comply with the requirements for clarity of solution stated under Parenteral Preparation as per IP 2014. |
154 |
NS (Sodium Chloride Injection I.P. 500ml) |
1511130 |
11/2015 |
10/2017 |
M/s. Haseeb Pharmaceuticals Pvt.Ltd., |
Plot No. F-9/15, MIDC, Nagpur – 440 016. |
Maharashtra |
09-11-2016. |
The sample does not complies for the test for Sterility as per IP. |
155 |
Sodium Chloride Injection I.P. (NS), |
1511117 |
11/2015 |
10/2017 |
M/s. Haseeb Pharmaceuticals Pvt.Ltd., |
Plot No. F-9/15, MIDC, Nagpur – 440 016. |
Maharashtra |
09-11-2016. |
The sample does not complies for the test for Sterility as per IP. |
156 |
Trapar |
MLS/T-109 |
07/2015 |
06/2017 |
M/s. Maven Life Sciences Pvt.td., |
185, Yallampet(V), Madchal (m), Ranga Reddy dist. Telangana. |
Telangana |
09-11-2016. |
The sample does not meet the Disintegration test for film coated tablets as per IP. |
157 |
Compound Sodium Lactate Injection I.P. |
164155 |
04/2016 |
03/2018 |
M/s. Haseeb Pharmaceuticals Pvt.Ltd. |
Plot No. F-9/15 MIDC, Nagpur – 440 016. |
Maharashtra |
17-01-2017. |
The sample does not complies for the test for Sterility as per IP.
Note: Label not as per IP. (Sodium Hydroxide IP 0.114gm not mentioned in IP formulation). |
158 |
Pralidoxime Chloride Injection IP, |
1604502 |
05/2016 |
04/2018 |
M/s. Concord Drugs Limited, |
Survey No.249, Brahmanapally village, Hayathnagar, Mandal, R.R. Dist, T.S. – 501 511. |
Telangana |
10-01-2017. |
The sample does not complies for the test for Sterility as per IP. |
159 |
Sodium Chloride Injection IP (NS), |
1511125 |
11/2015 |
10/2017 |
M/s. Haseeb Pharmaceuticals Pvt.Ltd. |
Plot No. F-9/15 MIDC, Nagpur – 440 016. |
Maharashtra |
17-01-2017. |
The sample does not complies for the test for Sterility as per IP. |
160 |
Sodium chloride Injection I.P., |
162164 |
02/2016 |
01/2018 |
M/s. Haseeb Pharmaceuticals Pvt.Ltd. |
Plot No. F-9/15 MIDC, Nagpur – 440 016. |
Maharashtra |
17-01-2017. |
The sample does not complies for the test for Sterility as per IP. |
161 |
Compound Sodium Lactate Injection I.P. |
16467 |
04/2016 |
03/2018 |
M/s. Haseeb Pharmaceuticals Pvt.Ltd. |
Plot No. F-9/15 MIDC, Nagpur – 440 016. |
Maharashtra |
17-01-2017. |
The sample does not complies for the test for Sterility as per IP.
Note: Label not as per IP. (Sodium Hydroxide IP 0.114gm not mentioned in IP formulation). |
162 |
Sodium Chloride Injection I.P., |
1511130 |
11/2015 |
10/2017 |
M/s. Haseeb Pharmaceuticals Pvt.Ltd. |
Plot No. F-9/15 MIDC, Nagpur – 440 016. |
Maharashtra |
28-01-2017. |
The sample does not complies for the test for Sterility as per IP. |
163 |
Degraded Gelatin Polymer PLASMA EXPANDER INFUSION, |
36573 |
07/2015 |
06/2017 |
M/s.Ives Drugs (India) Pvt.Ltd, |
Works: Ghatabillod, Dist. Dhar, H.O: 504,Chetak Centre, R.N.T. Marg, INDORE - 452001 (INDIA). |
Madhya Pradesh |
24-01-2017. |
The sample does not complies for the test for Sterility as per IP. |
164 |
Restat (Ethamsylate injection), |
7956 |
03/2015 |
02/2017 |
M/s.Ramson Remedies, |
186-187 Ind. Focal Point, Amritsar, A.O.2, G.floor, Baktawar, Malabar Hill, Mumbai – 6. |
Maharashtra |
10-01-2017. |
The sample does not complies for the test for description as per IP. |
165 |
Compound Sodium Lactate Injection (Ringer-Lactate Solution for Injection) |
93KE217036. |
05/2016 |
04/2019 |
M/s. Fresenius Kabi India Pvt.Ltd., |
Honda Industrial Estate, Plot No.1, Phase III, Honda, Sattari – 403 530. GOA. |
GOA |
05-01-2017. |
The sample does not complies for the test for Sterility as per IP. |
166 |
FYTON-TH, |
GTN-152225 |
12/2015 |
11/2017 |
M/s. GMH Laboratories, |
Plot NO.13, Industrial Township, Bhatoli-Lalan, Baddi, Dist: Solan (H.P). |
Himachal Pradesh |
09-02-2017. |
The sample does not meet the Assay for Aceclofenac as per label claim. |
167 |
OXO-200 (Ofloxacin Tablets I.P. 200 mg |
T-470/16 |
08/2016 |
07/2018 |
M/s. Spen Formulations Pvt.Ltd., |
Industrial Area, Mehatapur, Dist UNA - 174 315. |
|
31-03-2017. |
Does not complies uniformity of weight and Assay for Ofloxacin as per IP 2010. |
168 |
Furazolidone Tablets I.P. 100 mg, |
FR16-002 |
08/2016 |
07/2018 |
M/s. GREENLAND Organics, |
6-174-1, Industrial Area, Surampalli - 521 212. |
Andhra Pradesh |
28-02-2017. |
The sample does not meet IP Specifications for Uniformity of Weight and Assay content for Furazolidone. |
169 |
P Mol-650, |
PML1404 |
04/2014 |
03/2017 |
M/s. Pharmadeep Remedies |
Plt No. 62, Phase-IV, I.D.A., Cherlapally, Hyderabad - 51 (Telangana). |
Telangana |
23-06-2016 |
The tablets are found to be fragile and tablets are breaking while opening from the strip. As per IP the tablets should have sufficient strength to avoid crumbling or breaking on handling hence the sample does not meet the IP specifications with respect to description. |
170 |
Paraven 250 Suspension, |
MLS/L-128 |
12/2015 |
11/2017 |
M/s.Maven life sciences Pvt.Ltd., |
Plot No. 185, Yallampet (V), Medchal (M), Ranga Reddy Dist. Telangana. |
Telangana |
23-06-2016 |
The assay content does not complies as it is not within the limits of the label calim. Hence the sample is of NOT OF STANDARD QUALITY with respect to assay content. |
171 |
ONDANSETRON tb, IP-4mg, |
APON-03 |
03/2015 |
02/2018 |
M/s. Radico Remedies, |
123, Mandhala, Barotiwala, Dist. Solon, - 174 103 (H.P). |
Himachal Pradesh |
18-06-2016 |
The sample does not complies for the tests for dissolution as per IP and the assay content is not within the limits as per IP specifications. |
172 |
Chlorpheniramine Maleate Syrup I.P.''85 |
CM-219 |
11/2015 |
10/2017 |
M/s. Mino Pharm Laboratories Pvt.Ltd., |
Work. Opp. I.D.A., Pernamitta - 523 002. |
Andhra Pradesh |
16-06-2016 |
The sample does not meet the description test as the syrup contains some particles which is visible to the naked eye. But as per I.P. the oral liquids are homogeneous liquid preparations. Hence the sample is NOT OF STANDARD with respect to description as per IP. |
173 |
PENTASUN DM (Pantoprazole & Domperidone tablets), |
ST-15418 |
12/2015 |
11/2017 |
M/s. Sunlife sciences, |
130, kurdl, Jhabrera road, Manglour, Roorkee, Dist. Haridwar, U.K. |
Uttarakhand |
18-06-2016 |
The sample fails to meeth the disintegration test for enteric coated tablets since out of the 18 tablets tested, ALL the tablets disintegrated within 09minutes in 0.1M HCL. But as per I.P. NONE should disingtegration in 0.1M HCL for 02hours. Hence the sample is NOT OF STANDARD QUALITY with respect to disintegration test for enteric coated tablets as per IP. |
174 |
Compound Sodium Lactate Injection I.P., |
16530 |
05/2016 |
04/2018 |
M/s.Haseeb Pharmaceuticals Pvt.Ltd. |
Plot No. F-9/15 MIDC, Nagpur – 440 016. |
Maharashtra |
30-07-2016 |
"The sample does not complies the test for Sterility as per IP. Note: Label not as per IP. (Sodium Hydroxide IP 0.114gm not mentioned in IP formulation).
"The sample does not complies the test for Sterility as per IP. Note: Label not as per IP. (Sodium Hydroxide IP 0.114gm not mentioned in IP formulation).
" |