Annexure

List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, For the Month of October, 2014

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 / Roxyrab Suspensions / B. No. RAB-026,
D/Mfg. Jun, 2013,
D/Exp. May, 2015,
Mfd. By. M/s Regent Ajanta Biotech, 86-87, Vill-Makhiyali Dundi, Peerpura Road, Roorkee, Uttarakhand. / Misbranded
Report No. 09731/2014-15
Dated
09-10-2014 / CDSCO, East Zone / RDTL,
Guwahati
2 / Paracetamol Syrups / B. No. BM-128,
D/Mfg. Aug, 2014,
D/Exp. Jul, 2017,
Mfd. By. M/s Bee Dee Pharmaceuticals, Kalapahar Industrial Area, Guwahati, 781016, Assam. / Misbranded
Report No. 09751/2014-15
Dated
16-10-2014 / CDSCO, East Zone / RDTL,
Guwahati
3 / Bleaching Powder / B. No. NIL,
D/Mfg. May, 2013,
D/Exp. NIL, Packed By.
M/s J Industries, Guwahati-36 / Misbranded
Report No. RDTL/10/2014-15
Dated
22-10-2014 / CDSCO, East Zone / RDTL,
Guwahati
4 / K-DOX Injections / B. No. RSZ 25,
D/Mfg. Feb, 2013,
D/Exp. Jan, 2015,
Mfd. By. M/s Rainbow Laboratories, 158, New Industrial Area-II, Manideep, Dist-Raisen-462046. / Test for Sterility, BET Test
Report No. 09727/2014-15
Dated
08-10-2014 / CDSCO, East Zone / RDTL,
Guwahati
5 / Geenor-400 Tablets / B. No. NR4-192,
D/Mfg. Aug, 2012,
D/Exp. Jul, 2015,
Mfd. By. M/s Ghanshyam Pharmaceuticals, 14-16D, Rani Industrial Area, Kamrup-781131, Assam. / Dissolution
Report No. 09734/2014-15
Dated
10-10-2014 / CDSCO, East Zone / RDTL,
Guwahati
6 / Urotheral Catheter / B. No. KP-1031,
D/Mfg. Jul, 2013,
D/Exp. Jun, 2017,
Mfd. By. M/s Shree Umiya Surgical Pvt. Limited, 4704, GIDC, Phase-IV, Vatva, Ahmedabad-382445, Gujarat / Test for Sterility
Report No. 09742/2014-15
Dated
13-10-2014 / CDSCO, East Zone / RDTL,
Guwahati
7 / R-CEF-500 Capsules / B. No. RAB-108,
D/Mfg. Apr, 2014,
D/Exp. Mar, 2016,
Mfd. By. M/s Regent Ajanta Biotech, 86-87, Vill-Makhiyali Dundi, Peerpura Road, Roorkee, Uttarakhand. / Dissolution
Report No. 09784/2014-15
Dated
28-10-2014 / CDSCO, East Zone / RDTL,
Guwahati
8 / Moxmed 500 Capsules / B. No. VMC-4C002,
D/Mfg. Mar, 2014,
D/Exp. Feb, 2016,
Mfd. By. M/s Visa Drugs & Pharmaceuticals, Pvt. Limited.
Gullerwala, Near Sai Road, Baddi, Solan-173205, Himachal Pradesh. / Uniformity of Wt.
Report No. 09786/2014-15
Dated
28-10-2014 / CDSCO, East Zone / RDTL,
Guwahati
9 / Moxmed 500 Capsules / B. No. VMC-4C002,
D/Mfg. Mar, 2014,
D/Exp. Feb, 2016,
Mfd. By. M/s Visa Drugs & Pharmaceuticals, Pvt. Limited.
Gullerwala, Near Sai Road, Baddi, Solan-173205, Himachal Pradesh. / Uniformity of Wt.
Report No. 09787/2014-15
Dated
28-10-2014 / CDSCO, East Zone / RDTL,
Guwahati
10 / Depoxit Capsules (Fluoxetin Capsules IP) / B. No.: 2723
Mfg dt: 09/2012,
Exp dt: 08/2015
Mfd by: M/s. Olcare Laboratories 504/A, G.I.D.C. Estate, Wadhwancity 363035, Surendranagar, Gujarat / Dissolution
32-11/2014-SS/
DCA(A)-16/1526
Dt. 15.10.2014 / CDSCO, Sub Zone Ahmedabad / CDL, Kolkata
11 / Adrenaline Injection B.P. 1mg/ml / B. No.: N-3941
Mfg dt: 06/2014
Exp dt: 05/2017
Mfd by: M/s. Kwality Pharmaceutical Pvt. Ltd., Nag Kalan, Manjitha Road, Amritsar-India / Description & Particulate Matter
32-18/2014-SS/
DCA(C)-10/1550
Dt. 17.10.2014 / CDSCO, Sub Zone Chandigarh / CDL, Kolkata
12 / “Glumin Tablets” Metformin Hydrochloride Tablets IP / B.No: CB14007
Mfg. Dt: 05/2014
Exp. Dt: 04/ 2016
Mfd By: Ortin Laboratories Ltd, 275 & 278 (part), I.D.A
Pashamilaram- 502 307
Medak Dist. AP, INDIA. / Does not conform with respect to Test for Dissolution
(47.12 % to 64.54 % of Claim) / CDSCO, Zonal Office,
Hyderabad / CDTL, Chennai
13 / Zepara-XT Tablets (Paracetamol Tablets IP) / B.No: 414-1086
Mfg. Dt: 07/2014
Exp. Dt: 06/ 2016
Mfd By: Zee Laboratories,
47, Industrial Area
Paonta Sahib, 173075 (H.P) / Does not conform with respect to Test for Dissolution
(12.72 % to 32.48 % of Claim) / CDSCO, Zonal Office,
Hyderabad / CDTL, Chennai
14 / Rhydsetron-4 (Ondansetron Tablets IP 4 mg) / B.No.-T11- 12607, D/Mfg.-11/ 2012, D/Exp.-10/2014 Mfd. By – M/s Rhydburg Pharmaceuticals Ltd. (A WHO- GMP Certified Co.) C 2 & 3,S.I.E.L,Selaqui ,Dehradun-248197 / Does not conform to IP Standard with respect to the Test for Dissolution / CDSCO. Sub Zone, Goa / CDTL, Mumbai
15 / Metformin Hydrochloride Sustained-Release Tablets I.P.(GLYCIPHAGE SR 500 mg) / B. No –M14029
D/Mfg. –APR./2014
D/Exp. –MAR./2016
Mfd By-M/s. Franco-Indian Remedies Pvt. Ltd., 56 Nelson Manickam Road, Aminjikarai Chennai – 600029. / Dissolution
Report No. LSD/RDTL/0148/14-15
Date:- 13-10-14 / CDSCO, North Zone / RDTL Chandigarh
15 / Ciprofloxacin Hydrochloride Tablets I.P.(Neocip250) / B. No –CSR3104
D/Mfg. –OCT./2013
D/Exp. -SEP./2016
Mfd By-M/s. Shivalik Remedies Pvt. Ltd., Khasra No. 509/1-2 & 520, Village, Bhagwanpur – 247667, Dist. Haridwar, Uttarakhand. / Dissolution
Report No. LSD/RDTL/0260/14-15
Date:- 13-10-14 / CDSCO. Sub Zone, Chandigarh / RDTL Chandigarh
16 / Ibuprofen Tablets I.P. 400mg / B. No –TIB4-002
D/Mfg. –MAY./2014
D/Exp. –APR./2016
Mfd By-M/s. Medipol Pharmaceuticals India Pvt. Ltd., 1199/3, Bhud, Baddi, Dist. Solan, H.P., India. / Dissolution
Report No. LSD/RDTL/0306/14-15
Date:- 29-10-14 / CDSCO, North Zone / RDTL Chandigarh