YEAR 2016-2017 (NOVEMBER 1 to 30)
Sl. No. SAMPLE NAME
1 Kufdoz Baby (Cetirizine HCL,
Paracetamol & Phenylephrine HCL
Suspension)
2 Diclofenac Sodium Tablets IP
3 RBWEL (Rabeprazole Gastro
Resistant Tablets IP)
4 Polymol (Paracetamol Tablets IP
500mg)
5 Aciclovir Dispersible Tablets IP
200mg
6 Norfloxacin Tablets IP 400mg
7 Thyronil-50 (Thyroxine Sodium
Tablets IP)
8 Rabcid - 20 (Rabeprazole Sodium
Tablets IP)
9 sample does not conform to Label claim with
Segel-MPS (Aluminium Hydroxide,
Magnesium Hydroxide and
Simethicone Suspension)
10
Mebrosal (Syrup of Terbutaline,
Bromhexine & Guaiphenesin)
11
Salbutamol Sulphate Tablets IP
4mg
12 Enycold - BM
13 Metronidazole Tablets IP 200mg
14 Ambrovis-AP / Syrup Plus
15
Salbutamol Sulphate Tablets IP
4mg
16 Breacof Mucolytic Cough Syrup
17 Metronidazole Tablets IP 200mg
18 Paracetamol Tablets IP 500mg
B.NO. E/D M/S Reason for Failure Report No / Dated
S755233 02/2017 Scott-Edil Pharmacia Ltd. 56, E.P.I.P. Phase - I, sample does not conform to Label claim with 05609-D/2015-16/
Jhamajri - 173 205 respect to the content of Phenylephrine 03.11.2016
Hydrochloride
D-50207 01/2017 Sudarshan Pharmaceuticals Pvt. Ltd. 17-B, 18-A, sample does not conform to IP specification 02297-D/2016-17/
Sector - F, Industrial Area, Sanwer Road, Indore - for Enteric Coated Tablets with respect to 03.11.2016
452 015 (M.P) Disintegration in Acid Medium
WEL 1503 04/2017 Biomaarks Drugs India Pvt. Ltd. Ward No:1,NH- sample does not conform to IP specification 01954-D/2016-17/
22,Deonghat, Saproon, Solan -173 211, H.P. for Rabeprazole Gastro Resistant with respect 03.11.2016
to Dissoultion in Buffer Medium
INBA5001 05/2018 Ion Healthcare Pvt. Ltd. Baddi-Barotiwala Road, sample does not conform to IP specification 00015-D/2016-17/
Baddi, Solan District - 173 205, H.P. for Paracetamol Tablets with respect to 03.11.2016
Dissolution
T-15438 07/2017 Oyster Pharma Pvt. Ltd. Kumharhatti, Solan sample does not conform to IP specification 00938-D/2016-17/
District - 173 229, H.P. for Dispersible Tablets with respect to 03.11.2016
Distintegration and Uniformity of Dispersion
T150335 02/2017 Micron Pharmaceuticals, 2117, A-2, Phase - III, sample does not conform to IP specification 00704-D/2016-17/
G.I.D.C, Vapi - 396 195 for Norfloxacin Tablets with respect to 03.11.2016
Dissolution
T-13132 05/2017 East West Pharma, Unit-II, KH.No.196, Raipur sample does not conform to IP specification 06654-D/2015-16/
Industrial Area, Bhagwanpur, Roorkee, Haridwar for Thyroxine Sodium Tablets with respect to 03.11.2016
District - 274 661, Uttarakhand the content of Anhydrous Thyroxine Sodium
TCT15115 05/2017 Tychos Therapeutics Pvt. Ltd. D.P. No. 136, Sidco 06040-D/2015-16/
sample does not conform to IP specification
Industrial Estate, Thirumudivakkam, Chennai - 600 03.11.2016
for Rabeprazole Sodium Tablets with respect
044
to Dissolution in Buffer Medium
07170-D/2015-16/
Sree Sairam Pharmaceuticals, Vanur Taluk - 605 respect to the content of Simethicone 03.11.2016
SSP-837 09/2017
009, Tamil Nadu
sample does not conform to Label claim with 07217-D/2015-16/
Heamcure Pharmaceuticals Pvt. Ltd. No. 1,
L 786 09/2017 respect to the content of Terbutaline Sulphate 09.11.2016
Thangal Road, Poonamallee, Chennai - 600 056.
sample does not conform to IP specification 00413-D/2016-17/
Eurokem Laboratories Pvt. Ltd., Thiruporur, for Salbutamol Sulphate Tablets with respect 09.11.2016
SS141 02/2017
Alathur - 603 110 to the content of Salbutamol in Salbutamol
Sulphate
SP392 08/2017 Shape Pharma Pvt. Ltd. Plot No. 4, sample does not conform to label claim with 07459-D/2015-16/
Surendranagar, Rajkot Highway, Shekhpar, respect to the content of Bromhexine 14.11.2016
Gujarat Hydrochloride
MS14013 11/2017 Baader Schulz Laboratories Pharma Division, Plot sample does not conform to IP specification 03179-D/2016-17/
No.J-6, OIDC, Mahatma Gandhi Udyog Nagar, for Metronidazole Tablets with respect to 09.11.2016
Dabhel, Daman (U.T) India - 396 210 Dissolution
1501 03/2017 Saar Biotech, NH-21/A, Bhud, Baddi, Solan sample does not conform to Label claim with 07273-D/2015-16/
District - 173 205 H.P. respect to the content of Phenylephrine 09.11.2016
Hydrochloride
sample does not conform to IP specification 02816-D/2015-16/
Eurokem Laboratories Pvt. Ltd., Thiruporur, for Salbutamol Sulphate Tablets with respect 09.11.2016
SS141 02/2017
Alathur - 603 110 to the content of Salbutamol in Salbutamol
Sulphate
Baseman Health Care Inc, Thanakkankulam sample does not conform to Label claim with 06033-D/2015-16/
BHC1624 07/2018 Village, Madurai - 625 006,Tamil Nadu respect to the content of Bromhexine 09.11.2016
Hydrochloride
MS15014 03/2018 Baader Schulz Laboratories Pharma Division, Plot sample does not conform to IP specification 06608-D/2015-16/
No.J-6, OIDC, Mahatma Gandhi Udyog Nagar, for Metronidazole Tablets with respect to 09.11.2016
Dabhel, Daman (U.T) India - 396 210 Dissolution
36055-BTN17 04/2017 Biogenetic Drugs Pvt. Ltd. Jharmazri, Baddi, sample does not conform to IP specification 07537-D/2015-16/
Solan District - 174 103 H.P. for Paracetamol Tablets with respect to 09.11.2016
Dissolution
19
Dilocof (Terbutaline Sulphate,
Ambroxol HCL, Guaiphenesin with DLF-001
Menthol Syrup)
20 Linclox (Amoxycillin, Cloxacillin
with Lactic Acid Bacillus Capsules)
21 Risperidone Tablets USP 2mg
22 Povidone - Iodine Ointment USP
23 Dexamethasone Sodium
Phosphate Injection IP
24 Minorab (Rabeprazole Gastro
Resistant Tablets IP)
25 Rabivom - DSR (Rabeprazole
Sodium (Enteric Coated) &
Domperidone (Sustained Release)
26 Capsules)
Pomet (Pantoprazole Sodium
Tablets IP 40mg)
27 Bro-Zedex Expectorant
(Terbutaline Sulphate, Bromhexine
HCL, Guaiphenesin & Menthol
Syrup)
28 Role-Dom (Rabeprazole Sodium &
Domperidone SR Capsules)
29 Sodium Valproate Tablets IP
30 Pepzole - D (Rabeprazole Sodium
and Domperidone (Sustained HLCS 245
Release) Capsules)
31 Diclofenac Sodium Injection IP
32 Menthyl Ergometrine Maleate
Injection IP
33 Diclofenac Sodium Injection IP
sample does not conform to Label claim with 07323-D/2015-16/
Surien Pharmaceuticals (P) Ltd., Kovur, Chennai - respect to the content of Terbutaline Sulphate 09.11.2016
04/2017
602 101
AG 129 06/2017 Best Care Formulation Pvt. Ltd. Plot No. B-15&16, sample does not conform to IP specification 08767-D/2015-16/
Pipdic Electronic Park, Thirubuvanai, Puducherry - for Hard Gelatin Capsule with respect to 09.11.2016
605 107 Uniformity of weight and to label claim with
respect to the content of Cloxacillin in
Cloxacillin Sodium
415-1282 09/2017 Zee Laboratories, 47, Industrial Area, Paonta sample does not conform to USP specification 05927-D/2015-16/
Sahib - 173 025 H.P. for Risperidone Tablets with respect to the 14.11.2016
content of Risperidone and the sample is
deemed to be spurious since it is substituted
987 by another
02/2018 Super Formulations Pvt. Ltd. 16-B, 15-F, Industrial sample drug
does notondansetron Hydrochloride
conform to USP specification 03478-D/2016-17/
Area, Maxi Road,Ujjain - 456 010. M.P. for Povidone-Iodine Ointment with respect to 14.11.2016
the content of Available Iodine in Povidone
Iodine
HLI 505 M 11/2017 Himalaya Meditek (P) Ltd, Plot No. 35 & 36, sample does not conform to requirements for 358/ Laboratory No.
Pharmacity, Selaqui, Industrial Area, Dehradun - sterility and BET (within the limits of Indian 017/16-17/
248 197 Pharmacopoeia 2014) 14.11.2016
RAB 1502 05/2017 Biomaarks Drugs India Pvt. Ltd. Ward No. 1, NH- sample does not conform to IP specification 02487-D/2016-17/
22, Deonghat, Saproon, Solan District - 173 211 for Raberprazole Gastro Resistant Tablets 21.11.2016
JAN16218 12/2017 H.P.
Bonsai Pharma, Kishanpura, Baddi - Nalagarh with respect
sample doestonot
Dissoultion
conform toinLabel
Bufferclaim
Medium
with
03773-D/2016-17/
Road, P.O. Gurumajra, District Solan H.P. respect to the content of Rabeprazole Sodium 21.11.2016
Y2782 07/2017 DM Pharma, NH-21A, Vill Bhud, Baddi, Solan sample does not conform to IP specification 07809-D/2015-16/
District - 173 205 H.P. for Pantoprazole Tablets with respect to 21.11.2016
Dissoultion in Acid Medium
JQ10353 03/2017 Wockhardt Limited, 57, Kunjhal, Solan District - sample does not conform to Label claim with 05947-D/2015-16/
174 103. H.P. respect to the content of Bromhexine 21.11.2016
Hydrochloride
PP304 03/2017 Parwes (A Pharmaceutical Unit), B-37, Pipdic sample does not conform to Label claim with 00135-D/2016-17/
Electronic Park, Thirubhuvanai, Puducherry - 605 respect to the content of Rabeprazole Sodium 21.11.2016
107
4404 02/2017 Healthy Life Pharma Pvt. Ltd., Factory: N-31/1, sample does not conform to IP spectification 03689-D/2016-17/
M.I.D.C, Tarapur, District Thane, Boisar - 401 506. for Tablets with respect to General 21.11.2016
Description
Dr. Harry Life Sciences Pvt. Ltd. Old No. 27, New sample does not conform to Label claim with 08251-D/2015-16/
01/2018 No. 1/34, Leelavathy Nagar, Kundrathur Main respect to the content of Rabeprazole Sodium 21.11.2016
Road, Chikkarayapuram, Chennai - 69
DF 1533 12/2017 Nandani Medical Laboratories Pvt. Ltd., 221/15, sample does not conform to requirements for 381/ Laboratory No.
Bicholi Hapsi, Kanadia Road, Indore, M.P. description as per Indian Pharmacopoeia 344/16-17/
2014 21.11.2016
MET 1502 08/2017 Systochem Laboratories Ltd. B-75, Roop Nagar, sample does not conform to requirement for 388/ Laboratory No.
Industrial Area, Loni - 201 102, U.P. Sterility 031/16-17/
24.11.2016
HLI 509 M 11/2017 Himalaya Meditek (P) Ltd, Plot No. 35 & 36, sample does not conform to requirement for 389/ Laboratory No.
Pharmacity, Selaqui, Industrial Area, Dehradun - pH 238/16-17/
248 197 24.11.2016