Safety Drug Alert August 2014 - Not of Standard Quality Drugs - CENTRAL DRUGS STANDARD CONTROL ORGANIZATION

Sl. No.	Name of Drugs/medical device/cosmetics	Batch No./Date of Manufacture/Date of Expiry/Manufactured By	Reason for failure with Report No. (in Form-13)& Date	Drawn By	From
1	ERYTHROMYCIN ESTOLATE TABLETS	B. No. EE009, D/Mfg. Jul, 2013 , D/Exp. Jun, 2015, Mfg. By. M/s Hecatomb Laboratories Pvt. Ltd., Bagharbori, Panjabari, Guwahati-37, Assam.	Disintegration                                            09494/2014-15 Dated 04-08-2014	CDSCO, East Zone	RDTL, Guwahati
2	R-ZONE 20  TABLETS	B. No. RAB-113, D/Mfg. Apr, 2014, D/Exp. Mar, 2016, Mfg. By. M/s Regent Ajanta Biotech, Indl Site:86-87,Village-Makhiyali Dundi, Peerpura Road, Roorkeee, Uttarakhand.	Dissolution 09534/2014-15 Dated 13-08-2014	CDSCO, East Zone.	RDTL, Guwahati
3	ERYRAB SUSPENSIONS	B. No. RAB-068, D/Mfg. Jun, 2013, D/Exp. May, 2015, Mfg. By. M/s Regent Ajanta Biotech, 86-87, Village-Makhiyali Dundi, Peerpura Road, Roorkeee, Uttarakhand.	Description, Physical 09555/2014-15 Dated 19-08-2014	CDSCO, East Zone	RDTL, Guwahati
4	TINIDAZOLE WITH NORFLOXACIN DT TABLETS	B. No. NT-193, D/Mfg. Feb, 2012, D/Exp. Jan, 2015, Mfg. By. M/s Bee Dee Pharmaceuticals,, Kalapahar Industrial Area, Guwahati-781026, Assam.	Disintegration 09571/2014-15 Dated 26-08-2014	CDSCO, East Zone	RDTL, Guwahati
5	Metron (Metronidazole Tablets IP)	B.No. MRT-13003S, D/Mfg. Feb, 2013, D/Exp. Jan, 2016 Mfg. By. M/s. Indchemie Health Specialities Pvt. Ltd., Village-Kumrek, Rangpo, East Sikkim-737132	Dissolution	CDSCO, West Zone	CDTL, Mumbai
6	Chloroquine Phosphate Tablets I.P.	B.No. A2/190, D/Mfg. Jan, 2014, D/Exp. Dec, 2016 Mfg. By. M/s. Anchor Pharma Pvt. Ltd., B-6, O.I.D.C., Ringanwada, Daman-396210	Assay of Chloroquine Phosphate	CDSCO, West Zone	CDTL, Mumbai
7	Doxycycline Hydrochloride Capsules IP 100mg	B.No. GC73405, D/Mfg. Aug, 2013, D/Exp. July, 2016 Mfg. By. M/s. Globela Pharma Pvt. Ltd., 357, G.I.D.C., Sachin Surat-394230, Gujarat	Uniformity of Weight	CDSCO, West Zone	CDTL, Mumbai
8	Ibuprofen Tablets IP 400 mg	B.No:15033-BG137 D/Mfg. Mar, 2013 D/Exp. Feb, 2016/ Mfg. By. Biogenetic Drugs Pvt.Ltd, Jharmazri Baddi-174 103, Dist-Solan	Dissolution 18/11/330/14-15/	CDSCO, Hyderabad	CDTL, Chennai
9	Sumol Plus Suspension	B.No : SULS3010IB, D/Mfg. 08.2013, D/Exp. 07.2015 Mfg. By.-Alkem Laboratories Ltd, At.Village Thana, Baddi, Himachal Pradesh-173 205.	Assay Content of Mefenamic Acid 18/D/201/14-15	CDSCO, South Zone	CDTL, Chennai
10	Dinac-50 Tablets (Diclofenac Sodium Tablets IP)	B. No.: TNT-010, Mfg dt: 05/2013, Exp dt: 04/2016, Mfd by: M/s. Tanmed Pharmaceuticals, New No.1/429, Multi Industrial Nagar, Gerugambakkam, Chennai 600122	Disintegration 32-10/2014-SS/ DCA(S)-02/1078 Dt. 12.08.2014	CDSCO, South Zone.	CDL, Kolkata
11	Diclofenac Sodium IP,	B. No.: DS/01/13/085, Mfg dt: 29/07/13, Exp dt: 27/07/2018, Mfd by: M/s. Kairav Chemicals Ltd., Block No 2221, Vill: Santej, Tal: Kalol, Distt. Gandhinagar, Gujarat	Loss on Drying 32-9/2014-SS/ DCA(W)-78/1118 Dt. 19.08.2014	CDSCO, West Zone,	CDL, Kolkata
12	Lignocaine Hydrochloride and Adrenaline Injection IP	B. No.: LA 2106A, Mfg dt: 09/2012, Exp dt: 08/2014, Mfd by: M/s. Sara Pharmaceuticals, # 4 & 15, Industrial Estate, Nagercoil, Tamil Nadu.	Description, Particulate Matter & Assay 32-21/2014-SS/ DCA(G)-06/1007 Dt. 04.08.2014	CDSCO,  Subzone, Goa	CDL, Kolkata
13	MAHACEF-500 (Ceftriaxone Injection IP & Sterile Water for Injection IP 5 ml)	B.No: C3AAM003, R120076, Mfg dt: 12/2013, 11/2012, Exp dt: 11/2015, 10/2016, Mfd by: M/s. Mankind Pharma Limited, Kishanpura, Jamniwala, Teh: Paonta Sahib, Distt. Sirmour 173025, H.P & M/s. R.K Laboratories (P) Ltd., Village – Manpura, Nalagarh, Distt. Solan (H.P.) – 174 101.	Clarity of Solution 32-18/2014-SS/ DCA(C)-40/1079 Dt. 12.08.2014	CDSCO, Chandigarh	CDL, Kolkata
14	Rabfess Injection (Rabeprazole Sodium 20 mg Lyophillized Powder for Injection & Sterile Water for Injection BP),	B.No: VI0201, DEE01, Mfg dt: 06/2013, 05/2012, Exp dt: 06/2015, 04/2018, Mfd by: M/s. Biomed Life Sciences, 5 Dewan & Sons, Lokmanya Nagar, Palghar (W), Thane – 401 404, India.	Clarity of Solution & Particulate Matter 32-18/2014-SS/ DCA(C)-02/1031 Dt. 08.08.2014	CDSCO,       Chandigarh	CDL, Kolkata
15	Cetriax – 1gram (Ceftriaxone for  Injection USP & Sterilised Water for Injection BP 10 ml),	B.No: 4404913, 3502272 Mfg dt: 10/2013, 02/2013 Exp dt: 09/2016, 01/2018, Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Ltd., Plot No. 14, II Phase, Peenya, Bangalore 560058 & M/s. Nirma Ltd., Sachana, Gujrat – 382150	Clarity of Solution, Compleateness & Particulate Matter 32-13/2014-SS/ DCA(B)-74/1080 Dt. 12.08.2014	CDSCO, SubZone Bangalore	CDL, Kolkata
16	Ramipril Tablets IP 2.5mg (Eldapril 2.5),	B. No.: ARKB 3054, Mfg dt: 04/2013, Exp dt: 03/2015, Mfd by: M/s. Kanha Biogenetic Laboratories, Pl.No. 1-B, EPIP, Phase-I, Jharmajri, Baddi, Solan (HP).	Assay 32-8/2014-SS/ DCA(E)-327/1088 Dt. 14.08.2014	CDSCO, East Zone	CDL, Kolkata
17	SALBUTAMOL TABLETS I.P. 2 mg	Batch No – AT-13121, D/Mfg.    ­– SEP./2013, D/Exp.  – AUG./2015, Mfd. By- M/s. ARBRO PHARMACEUTICAL LTD., 6/14, Kirti Nagar, Industrial Area, New Delhi-110015.	Assay RDTL/757/13-14 Date:- 08-08-14	CDSCO,,  North Zone	RDTL, CHandigarh
18	SALBUTAMOL TABLETS I.P. 4 mg	Batch No – SSMT-1004, D/Mfg.    ­– JUL./2013, D/Exp.    – JUN./2015, Mfd. By- M/s. WINGS PHARMACEUTICAL LTD, 35, HPSIDC, Industrial Area, Baddi-173205.	Assay RDTL/768/13-14 Date:- 08-08-14	CDSCO, North Zone	RDTL, Chandigarh
19	Ranitidine Hydrochloride Tablets B.P.   (MANTEK-150)	Batch No – MT13-011, D/Mfg.    ­– APR./2013, D/Exp.    – MAR./2016, Mfd. By- M/s. MAIDEN PHARMACEUTICALS LIMITED, 81, H.S.I.D.C, Industrial Area, Kundli, 131 028 (HR)	Uniformity of weight and Assay RDTL/893/13-14 Date:- 08-08-14	CDSCO, North Zone	RDTL, Chandigarh
20	Diclofenac Sodium Gel 1% (SPORT GEL)	Batch No –  BO-2, D/Mfg.    ­– MAR./2014, D/Exp.    – FEB./2017, Mfd. By- M/s. Caplin Laboratories Ltd., At.Argus Salud Pharma LLP, Khasra No.380, Village Suraj Majra, NH-21A, Baddi, H.P.	Assay  of Diclofenac Diethylamine LSD/RDTL/0017/14-15 Date:- 27-08-14	CDSCO, Sub Zone, Chandigarh.	RDTL, Chandigarh
21	Serratiopeptidase, DIclofenac Sodium and Paracetamol Tablets (Sendic Plus)	Batch No – 7030 D/Mfg.    ­– AUG./2013                 D/Exp.    – JUL./2015 Mfd. By- M/s. Santo Formulation, Deonghat, P.O. Saproon, Distt.Solan-173211(H.P.)	Assay of   Serratiopeptidase LSD/RDTL/0038/14-15 Date:- 27-08-14	CDSCO, J& K,	RDTL, Chandigarh
22	Rabeprazole and Domperidone Sustained Release Caps (Rabela DSR Caps)	Batch No – DMC-81 D/Mfg.    ­– MAR./2014 D/Exp.    – AUG./2015 Mfd. By- M/s. Dallas Formulations P Ltd., 144, DIC, Industrial Area, Sai Road, Baddi. (HP)	Assay of Rabeprazole Sodium LSD/RDTL/001/14-15 Date:- 29-08-14	CDSCO, Sub Zone, Chandigarh.	RDTL, Chandigarh