Annexure

List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, For the Month of November, 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 / Paracetamol Syrups / B. No. RL-276,
D/Mfg. Apr, 2014,
D/Exp. Mar, 2016,
Mfg. By.
M/s Ratnamani Healthcare Pvt. Limited,
Survey No. 750/1, Ahmedabad-Mehsana Highway, Vill-Indrad, Tal-Kadi, 382721, Gujarat. / Misbranded
Report No. 09881/2014-15
Dated
25-11-2014 / CDSCO, East Zone / RDTL,
Guwahati
2 / Rabcam-20 Tablets / B. No. RAB-078,
D/Mfg. Nov, 2013,
D/Exp. Oct, 2015,
Mfg. By.
M/s Regent Ajanta Biotech,
86-87, Vill-Makhiyali Dundi, Peerpura Road, Roorkee, Uttarakhand, 247667. / Misbranded
Report No. 09882/2014-15
Dated
25-11-2014 / CDSCO, East Zone / RDTL,
Guwahati
3 / Roxycept-150 Tablets / B. No. V13A-069,
D/Mfg. Jan, 2013,
D/Exp. Dec, 2014,
Mfg. By.
M/s Venus Biosciences Pvt. Ltd.,
116, Export Promotion Indl Park, Phase-I, Jharmajri, Baddi, Dist-Solan, 173205, Himachal Pradesh. / Dissolution
Report No. 09811/2014-15
Dated
07-11-2014 / CDSCO, East Zone / RDTL,
Guwahati
4 / Paracetamol Tablets / B. No. 060114,
D/Mfg. Jan, 2014,
D/Exp. Dec, 2016,
Mfg. By.
M/s Veejay Laboratories,
EPIP Zone, Amingaon, Guwahati-781031, Assam. / Dissolution Report No. 09832/2014-15
Dated
14-11-2014 / CDSCO, East Zone / RDTL,
Guwahati
5 / Paracetamol Tablets / B. No. 010114,
D/Mfg. Jan, 2014,
D/Exp. Dec, 2016,
Mfg. By.
M/s Veejay Laboratories,
EPIP Zone, Amingaon, Guwahati-781031, Assam. / Dissolution
Report No. 09833/2014-15
Dated
14-11-2014 / CDSCO, East Zone / RDTL,
Guwahati
6 / Fenela – P Tablet / B. No. EIG-1307,
D/Mfg. Jul, 2013,
D/Exp. Jun, 2015,
Mfg. By.
M/s Everest Formulations,
Saproon, Solan, 173211, Himachal Pradesh. / Disintegration Report No. 09866/2014-15
Dated
20-11-2014 / CDSCO, East Zone / RDTL,
Guwahati
7 / Flexon Tablets / B. No. MM26K553,
D/Mfg. Oct, 2013,
D/Exp. Sep, 2016,
Mfg. By.
M/s Aristo Pharmaceuticals Pvt. Limited,
Plot No. 208, Dist-Raisen, Madhya Pradesh. / Disintegration Report No. 09867/2014-15
Dated
20-11-2014 / CDSCO, East Zone / RDTL,
Guwahati
8 / Boss-OZ Tablets / B. No. D30145,
D/Mfg. Apr, 2013,
D/Exp. Mar, 2015,
Mfg. By.
M/s Arion Healthcare.
Vill-Kishanpura, Baddi, Dist-Solan, 174101. / Disintegration Report No. 09865/2014-15
Dated
20-11-2014 / CDSCO, East Zone / RDTL,
Guwahati
9 / PMO-650 Tablets / B. No. LPMT-13001S,
D/Mfg. Mar, 2013,
D/Exp. Feb, 2016,
Mfg. By.
M/s Indchemie Health Specialities Pvt. Limited,
Vill-Kumerk, Rangpo, East-Sikkim, 737132, Sikkim. / Dissolution Report No. 09879/2014-15
Dated
25-11-2014 / CDSCO, East Zone / RDTL,
Guwahati
10 / Oflomin-OZ Tablets / B. No. RAB-111,
D/Mfg. Apr, 2014,
D/Exp. Mar, 2016,
Mfg. By.
M/s Regent Ajanta Biotech,
86-87, Vill-Makhiyali Dundi, Peerpura Road, Roorkee, Uttarakhand, 247667. / Disintegration Report No. 09883/2014-15
Dated
25-11-2014 / CDSCO, East Zone / RDTL,
Guwahati
11 / Cyanocobalamine Injection IP / B. No.: 46/B
Mfg dt: 01/2014,
Exp dt: 06/2015
Mfd by: M/s. Good Kare Medico (P) Ltd., E-6, Industrial Estate, Delhi Road, Saharanpur, UP / Particulate Matter & Description
32-1/2014-SS/
DCA(N)-7/1663
Dt. 17.11.2014 / CDSCO, North Zone / CDL, Kolkata
12 / Sulbactomax (Ceftriaxone/Sulbactum for Injection) / B. No.: DV3G583
Mfg dt: 07/2013
Exp dt: 06/2015
Mfd by: M/s. Venus Remedies Ltd., Hill Top Industrial Estate, Jharmajri, EPIP, Phase-I
(Extn.), Bhatoli, Kalan,
Baddi 173205, HP. / Appearance after reconstitution & Particulate Matter
32-18/2014-SS/DCA(C)-28/1664
Dt. 17.11.2014 / CDSCO, Sub Zone, Chandigarh / CDL, Kolkata
13 / Roller Bandage 10 cms x 4 mts / B. No.: 1373
Mfg dt: 09/2013,
Exp dt: 08/2016
Mfd by: M/s. Atin Cottage Industries, 36-A, Beniapukur Road, Kolkata 700 014. / Description, Threads per dm, Weight in g/m2, Length, Foreign Matter, Fluorescence
32-8/2014-SS/
DCA(E)-141/1678
Dt. 17.11.2014 / CDSCO, East Zone / CDL, Kolkata
14 / Dexon (Dexamethasone Sodium Phosphate Injection IP) / B. No.: L13D01007
Mfg dt: 08/2013
Exp dt: 07/2015
Mfd by: M/s. N.I. Pharmaceutical Works (P) Ltd., Boral Main Road, Paschim Nischintapur, Bagher Ghole, Kolkata 700 103 / Assay of Dexamethasone
32-8/2014-SS/
DCA(E)-3/1677
Dt. 17.11.2014 / CDSCO, East Zone / CDL, Kolkata
15 / Centradol 100 (Tramadol Hydrochloride Injection) / B. No.: TAM3F1
Mfg dt: 04/2013,
Exp dt: 03/2015
Mfd by: M/s. Tablets (India) Ltd., 179, T.H. Road, Chennai 600081 / Description & Particulate Matter
32-8/2014-SS/
DCA(E)-253/1711
Dt. 24.11.2014 / CDSCO, East Zone / CDL, Kolkata
16 / Nirsal-BR Syrup / B. No.: 8L20614
Mfg dt: 12/2012
Exp dt: 11/2014
Mfd by: M/s. Nirma Limited (Healthcare Division), Sachana, Gujarat – 382150, India. / Assay of Bromhexine Hydrochloride
32-11/2014-SS/
DCA(A)-122/1734
Dt. 25.11.2014 / CDSCO, Zonal Office, Ahmedabad / CDL, Kolkata
17 / Zepara-XT Tablets
( Paracetamol Tablets IP 650 mg ) / B.No: 414-1247
Mfd. Dt: 07/2014
Exp. Dt: 06/ 2016
Mfd By: Zee Laboratories,
47, Industrial Area,
Paonta Sahib, 173 025 (H.P) / Does not conform with respect to Test For Dissolution
( 44.9 % to 73 % of Claim)
Regn.No: CDTL/Form-18/D/641/14-15 / CDSCO, Zonal Office, Hyderabad / CDTL, Chennai
18 / Cardem-30
(Ditliazem Tablets IP) / B.No: 03402P
Mfd. Dt: March 2014
Exp. Dt: August 2016
Mfd By: AFD Laboratories Pvt. Ltd,
At: Plot, No.4, Phase-II,
Peenya Industrial, Peenya,
Bangalore-560 058. / Does not conform with respect to Test For Dissolution
( 35.03 % to 45.46 % of Claim)
Regn.No: CDTL/Form-18/D/703/14-15 / CDSCO, Zonal Office, Hyderabad / CDTL, Chennai
19 / Fruron Tablets
( Frusemide and Spironolactone Tablets) / B.No: ZT- 6991
Mfd. Dt: 03/2014
Exp. Dt: 02/2016
Mfd By: Zee Laboratories,
47, Industrial Area,
Paonta Sahib -173 025 (H.P) / Does not conform with respect to Assay of Frusemide
( 0.568 % of Claim)
Regn.No: CDTL/Form-18/D/382/14-15 / CDSCO, Zonal Office, Hyderabad / CDTL, Chennai
20 / Digestive Enzyme B-Complex with L-Lysine (Xzyme Syrup) / B.No: AK1892
Mfd. Dt:- May/2014
Exp. Dt: -Oct/2015
Mfd By: M/s. Affy Pharma Pvt. Ltd., Village Thana, Baddi- Distt. Solan,, (H.P.) / Assay of Thiamine Mononitrate
Report No. LSD/RDTL/0071/14-15
Date:13-11-14 / CDSCO, Sub Zone, Chandigarh / RDTL,
Chandigarh
21 / Sodium Valproate & Valproic Acid Controlled Release Tablets® (SV CHRONO-300) / B.No: LC13-249
Mfd. Dt: -08/2013
Exp. Dt: -07/2016
Mfd By: - M/s. Lifecare Neuro Products Ltd., 70/1, Dharampur, Near EPIP-II, Baddi-173205, Himachal Pradesh. / Assay of Sodium Valproate & Valproic Acid
Report No. RDTL/845/13-14
Dated:-17-11-14 / CDSCO, Sub Zone, Jammu / RDTL,
Chandigarh
22 / Ondansetron Tablets IP (OND-MIN-8) / B.No: -1122
Mfd. Dt: -Jul./2013
Exp. Dt: -Jun./2015
Mfd By: - M/s. Minil Laboratories Pvt. Ltd., 26, Industrial Estate, Jammu-180010. / Assay of Ondansetron Hydrochloride calculated as Ondansetron
Report No. LSD/RDTL/0191/14-15
Dated:-28-11-14 / CDSCO, Sub Zone, Jammu / RDTL,
Chandigarh
23 / Cefpodoxime Tablets IP (Zextil-200) / B.No: ZT-14103
Mfd. Dt: -02/14
Exp. Dt: -01/16
Mfd By: - M/s. Zee Laboratories, 47, Industrial Area, Paonta Sahib, Distt. Sirmour H.P.173025 / Dissolution
Report No. LSD/RDTL/0256/14-15
Dated:-25-11-14 / CDSCO, Sub Zone, Chandigarh / RDTL,
Chandigarh
24 / Ciprofloxacin Hydrochloride Tablets IP (Cipmah-500) / B.No: MAT1349
Mfd. Dt: -10/13
Exp. Dt: -09/15
Mfd By:- M/s. Mediaid Health Care Pvt. Ltd., Plot No. 88, Sector-7, IIE, SIDCUL, Haridwar (U.K.) / Dissolution & Assay
LSD/RDTL/0320/14-15
Dated:-26-11-14 / CDSCO, North Zone / RDTL,
Chandigarh