List of Drugs, Medical Devices and Cosmetics Declared As Not of Standard

List of Drugs, Medical Devices and Cosmetics Declared As Not of Standard

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