Drug Alert for the Month of May 2014

S.No. / Name of the Drug/Medical Device/Cosmetic / B.No., D/M, D/E, Name of the Mfg. & Address / Reason for Failure with report in Form 13/34 No. & Date / Drawn By / From
1 / Diclofenac Sodium tablets / B.No.08123-BG151
Mfg. Dt. 12-2013
Exp. Dt. 11-2016
Mfg. By: M/s. Biogenetic Drugs Pvt Ltd., Jharmajri, Baddi-174103, H.P. / Disintegration Test
CDTL/F18/D/209/14-15 Dt. 30-05-2014 / CDSCO, South Zone / CDTL, Chennai
2 / Ibuprofen Tablets / B.No.4610
Mfg. Dt. 06-2013
Exp. Dt. 05-2015
Mfg. By: M/s.Vikram Laboratories (P) Ltd., behind Tubewell Colony, Meerut Road, Muzaffarnagar-251002 (U.P.) / Assay & Dissolution
CDTL/F18/D/104/14-15 Dt. 30-05-2014 / CDSCO, South Zone / CDTL, Chennai
3 / Elispirin 150 Tablets
(Enteric Coated Aspirin Tablets) / B.No.ELP-122
Mfg. Dt. 12-2013
Exp. Dt. 11-2015
Mfg. By: M/s. Embiotic Laboratories (P) Ltd., 20C, Kumbalgodu Industrial Area, 1st Phase Kumbalgodu, Bangalore-560074 / Dissolution
CDTL/F18/11/177/14-15 Dt. 30-05-2014 / CDSCO, South Zone / CDTL, Chennai
4 / Serratiopeptidase Tablets IP 10mg / B.No. BUK-014
Mfg. Dt. 03-2013
Exp. Dt. 02-2015
Mfg. By: M/s. BHC lab Pvt Ltd., 91/2, DIC, Baddi, Solan H.P.-173205 / Assay
RDTL/561/13-14 Dt. 13-05-2014 / CDSCO North Zone / RDTL, Chandigarh
5 / Alprazolam Tablets (Agcalm-0.25) / B.No. HCM-03
Mfg. Dt. 06-2013
Exp. Dt. 05-2016
Mfg. By: M/s. Agron Remedies Pvt Ltd., Sarverkhera, Moradabad Road, Kashipur (U.K.) / Assay
RDTL/567/13-14 Dt. 27-05-2014 / CDSCO North Zone / RDTL, Chandigarh
6 / Rabeprazole&Domperidon tablets (Rappi-D) / B.No. T-130577
Mfg. Dt. 07-2012
Exp. Dt. 06-2014
Mfg. By: M/s. MerrilPharmaPvt. Ltd., Plot No. 212, B/h P.G. International, Raipur, Bhagwanpur, Roorkee (UA) / Disintegration Test
RDTL/608/13-14 Dt. 13-05-2014 / CDSCO North Zone / RDTL, Chandigarh
7 / CefpodoximeProxetil Tablets I.P. (CP-200) / B.No. ULT-5454
Mfg. Dt. 10-2013
Exp. Dt. 09-2015
Mfg.By: M/s. Ultratech Pharmaceuticals Vill. Tipra, Haripur Road, P.O. Barotiwala, Solan (H.P.) / Dissolution
RDTL/627/13-14 Dt. 13-05-2014 / CDSCO Sub Zone Chandigarh / RDTL, Chandigarh
8 / Lignotox 2% (Lignocaine & Adrenaline Injection IP) / B.No. JT06
Mfg. Dt. 10-2012
Exp. Dt. 09-2014
Mfg. By: M/s. J.L.Morison (India) Ltd., Worli, Mumbai-400018 / Description & particulate matter
32-20/2014-SS/DCA(J)-17/176 Dt. 06-05-2014 / CDSCO North Zone / CDL, Kolkata
9 / Artfin 60mg Injection (Artesunate for Injection) / B.No. D-1779
Mfg. Dt. 07-2013
Exp. Dt. 06-2015
Mfg. By: M/s. Zee laboratories, 47, Industrial Area, Poanta Sahib 173205 / Sterility Test & bacterial Endotoxin for Sodium Chloride Injection supplied along with sample as diluent 32-1/2014-SS/DCA(N)-47/177 Dt. 06-05-2014 / CDSCO North Zone / CDL, Kolkata
10 / Lidocaine Ointment USP / B.No. 735
Mfg. Dt. 08-2012
Exp. Dt. 07-2014
Mfg. By: M/s. Ciron Drugs & Pharmaceuticals Pvt. Ltd. N-118, 119, MIDC, Tarapur, Boisar, Thane-401506 / Assay
32-9/2014-SS/DCA(W)-3/232 Dt.19-05-2014 / CDSCO West Zone / CDL, Kolkata
11 / Ondot (Ondansetron Injection USP 2ml) / B.No. OND-1015
Mfg.Dt. 09-2012
Exp. Dt. 08-2014
Mfg. By: M/s. Crystal Pharmaceuticals, 365, Model Town, Ambala City 134003 / Assay of Ondansetron
32-1/2013-SS/DCA(N)-40/280 Dt. 30-05-2014 / CDSCO North Zone / CDL, Kolkata
12 / Trypsin Chymotrypsin Tablets / B.No. NT0103004
Mfg.Dt. 09-2013
Exp. Dt. 08-2016
Mfg. By: M/s. Elder Pharmaceuticals Ltd., D-220, TTC Industrial Area, Navi Mumbai-400706 / Assay of Trypsin Chymotrypsin (total Proteolytic Activity)
32-9/2014-SS/DCA(W)-95/290 Dt.30-05-2014 / CDSCO West Zone / CDL, Kolkata
13 / Ibuprofen Tablets / B.No. IB4-7050
Mfg.Dt. 05-2011
Exp. Dt. 04-2014
Mfg. By: M/s. Lark Laboratories (India) Ltd., SP-1192E, Phase-IV RIICO Industrial Area, Rajasthan-301019 / Dissolution
09183/2014-15 Dt. 13-05-2014 / Drugs Control Dept., Arunachal Pradesh / CDTL, Guwahati
14 / Paracetamol, Propyphenazone& Caffeine Tablets / B.No. 09210
Mfg.Dt. 09-2012
Exp. Dt. 08-2015
Mfg. By: M/s. JuggatPharma, (Pharma Division of Jagdale Industries Ltd.), 47/1, 20th km., Mysore Road, Bangalore-560060 / Disintegration
09185/2014-15 Dt. 15-05-2014 / Drugs Control Dept., Assam / CDTL, Guwahati
15 / Dart Tablets / B.No. 10225
Mfg.Dt. 10-2012
Exp. Dt. 09-2015
Mfg. By: M/s.JuggatPharma, (Pharma Division of Jagdale Industries Ltd.), 47/1, 20th km., Mysore Road, Bangalore-560060 / Disintegration
09206/2014-15 Dt. 21-05-2014 / Drugs Control Dept., Assam / CDTL, Guwahati
16 / Erythromycin Estolate Tablets / B.No. 10225
Mfg.Dt. 10-2012
Exp. Dt. 09-2015
Mfg. By: M/s. Hecatomb Laboratory Pvt. Ltd., Baghorbori, Panjabari, Guwahati-781037 / Disintegration, Uniformity of Weight
09232/2014-15 Dt. 28-05-2014 / Drugs Control Dept., Assam / CDTL, Guwahati