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

http://www.cdsco.nic.in/forms/list.aspx?lid=1825&Id=33

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
FLEXON TABLETS
B. No. MM26F493,
D/Mfg. Jun, 2013 ,
D/Exp. May, 2016,
Mfg. By.
M/s Aristo Pharmaceuticals,
Plot 208, New Industrial Area No. 2, Mandideep, Dist-Raisen, Madhya Pradesh.
Disintegration
09395/2014-15
Dated
07-07-2014

CDSCO, East Zone
RDTL, Guwahati
2
MERICOL – 500 TABLETS
B. No. WSZ 1309,
D/Mfg. Jun, 2013,
D/Exp. May, 2016,
Mfg. By.
M/s Shivek Labs Ltd.,
Village-Kishanpura, Baddi-Nalagarh Road, Dist-Solan, Himachal Pradesh-174101.
Dissolution
09420/2014-15
Dated
15-07-2014

CDSCO, East Zone
RDTL, Guwahati
3
MERICOL – 500 TABLETS
B. No. WSZ1311,
D/Mfg. Jan, 2013,
D/Exp. Dec, 2016,
Mfg. By.
M/s Shivek Labs Ltd.,
Village-Kishanpura, Baddi-Nalagarh Road, Dist-Solan, Himachal Pradesh-174101.
Dissolution
09452/2014-15
Dated
21-07-2014

CDSCO, East Zone
RDTL, Guwahati
4
CEFVERT – 100 DT TABLETS
B. No. CPMKA-3541,
D/Mfg. Oct, 2013,
D/Exp. Sep, 2015,
Mfg. By.
M/s J. M. Remedies,
Mamoore Complex, Saproon, Solan, Himachal Pradesh-173211.
Uniformity of Weight
09451/2014-15
Dated
21-07-2014

CDSCO, East Zone
RDTL, Guwahati
5
SANOFLOX –OZ TABLETS
B. No. DMT-038,
D/Mfg. Apr, 2013,
D/Exp. Mar, 2015,
Mfg. By.
M/s Mittal Laboratories Pvt. Limited,
Sara Industrial Estate Ltd., Village-Rampur, Selaqui, Dehradun, Uttarakhand.
Disintegration
09458/2014-15
Dated
23-07-2014
CDSCO, East Zone
RDTL, Guwahati
6
PARACETAMOL TABLETS
B. No. 300414,
D/Mfg. Apr, 2014,
D/Exp. Mar, 2017,
Mfg. By.
M/s Veejay Laboratories, EPIP Zone, Amingaon, Guwahati, Assam-781031.
Dissolution
09467/2014-15
Dated
25-07-2014
CDSCO, East Zone
RDTL, Guwahati
7
PARACETAMOL TABLETS
B. No. 180414,
D/Mfg. Apr, 2014,
D/Exp. Mar, 2016,
Mfg. By.
M/s Veejay Laboratories, EPIP Zone, Amingaon, Guwahati, Assam-781031.
Dissolution and Uniformity of Weight
09468/2014-15
Dated
25-07-2014
CDSCO, East Zone
RDTL, Guwahati
8
RABMOL – 500 TABLETS
B. No. RAB-110,
D/Mfg. Apr, 2014,
D/Exp. Mar, 2016,
Mfg. By.
M/s Regent Ajanta Biotech,
86-87, Village-MakhiyaliDundi, Peerapura Road, Roorkee, Uttarakhand.
Dissolution
09472/2014-15
Dated
25-07-2014
CDSCO, East Zone
RDTL, Guwahati
9
PARACETAMOL TABLETS
B. No. 190414,
D/Mfg. Apr, 2014,
D/Exp. Mar, 2016,
Mfg. By.
M/s Veejay Laboratories, EPIP Zone, Amingaon, Guwahati, Assam-781031.
Dissolution
09473/2014-15
Dated
25-07-2014
CDSCO, East Zone
RDTL, Guwahati
10
PARACETAMOL TABLETS
B. No. 260414,
D/Mfg. Apr, 2014,
D/Exp. Mar, 2017,
Mfg. By.
M/s Veejay Laboratories, EPIP Zone, Amingaon, Guwahati, Assam-781031.
Dissolution
09474/2014-15
Dated
25-07-2014
CDSCO, East Zone
RDTL, Guwahati
11


Bupivacaine Heavy (Bupivacaine Hydrochloride & Dextrose Injection USP)
B. No.: I-3864                                     Mfgdt: 05/2013, Expdt: 04/2015, Mfd by: M/s. Jackson Laboratories Pvt. Ltd., Bye Pass, Majitha Road, Amritsar 143004
Description, Particulate Matter & Assay 32-1/2014-SS/DCA(N)-01/846            Dt. 21.07.2014
CDSCO, North Zone
CDL, Kolkata
12
Compound Sodium Lactate Injection IP 500 ml,
B. No.: P13D-612                               Mfgdt: 01/2013, Expdt: 12/2015, Mfd by: M/s. Parentral Drugs (I) Ltd., Vill: Sura, Suranusi, Jalandhar 144027
Assay of Sodium         32-1/2014-SS/DCA(N)-72/923            Dt. 25.07.2014
CDSCO, North Zone
CDL, Kolkata
13
Mefcin Forte (Mefanamic Acid &Paracetamol Tablets)
B. No.: MCF-020                                 Mfgdt: 07/2012, Expdt: 06/2014, Mfd by: M/s. Suzikem Drugs Pvt. Ltd., Plot No. 205/2A, IDA, Cherlapalli, Phase II, RR Dist 500051
Disintegration  32-12/2014-SS/DCA(H)-180/873            Dt. 23.07.2014
CDSCO, SubZone Hyderabad
CDL, Kolkata
14
Combipack of Artesunate Injection, Sodium Bicarbonate & Sodium Chloride Injection IP,
B.No: P2284,P2246,P2247Mfgdt: 10/2012, 09/2012, 09/2012, Expdt: 09/2014, 08/2015, 08/2015, Mfd by: M/s. Bharat Parenterals Ltd., Haripura, Tal. Savli, Vadodara 391520
Particulate Matter & Clarity of Solution         32-9/2014-SS/DCA(W)-09/872           Dt. 23.07.2014
CDSCO, West Zone
CDL, Kolkata
15
Numbcaine Heavy 20mg/4ml (Bupivacaine Hydrochloride in Dextrose Injection USP),
B. No.: 2NUB12                                 Mfgdt: 01/2014, Expdt: 12/2015, Mfd by: M/s. Samarth Life Science Pvt. Ltd., Unit-II, Plot No. 2, Industrial Area, Lodhimajra, Baddi, H.P. 173205.
Description & Particulate Matter             32-20/2014-SS/DCA(J)-04/771            Dt. 03.07.2014
CDSCO, Sub-Zone, Jammu
CDL, Kolkata
16
Flexon (Ibuprofen &Paracetamol Tablets),
B. No.: D26C112                                   Mfgdt: 03/2012, Expdt: 02/2015, Mfd by: M/s. Aristo Pharmaceuticals Pvt. Ltd., Survey No. 371, KunbarFalia, Dabhel, Nani Daman 396210.
Disintegration 32-8/2014-SS/DCA(E)-123/911         Dt. 25.07.2014
CDSCO, East Zone
CDL, Kolkata
17
Niclo (Diclofenac Sodium Injection IP 3ml)
B. No.: L13D04017                                    Mfgdt: 08/2013, Expdt: 07/2016, Mfd by: M/s. N.I. Pharmaceutical Works (P) Ltd., Boral Main Road, PaschimNischintapur, BagherGhole, Kolkata 700 103, W.B.
Extractable Volume & Particulate Matter                   32-8/2014-SS/DCA(E)-05/868                  Dt. 22.07.2014
CDSCO, East Zone
CDL, Kolkata
18
Rifampicin Capsules BP 300 mg (RIFAMLIFE)

Batch No – RFM001                                 D/Mfg.    ­– 05/2012, D/Exp.    – 05/2015, Mfd. By- M/s. EUROLIFE HEALTHCARE PVT.LTD., 69-A, Mittal Chambers, Nariman Point,  Mumbai-400 021.

Dissolution RDTL/897/13-14                 Date:- 14-07-14

CDSCO, North Zone
RDTL, Chandigarh
19
C-Biotic Ear Drop

Batch No – ULO-4419                           D/Mfg.    ­– SEP./13, D/Exp.    – AUG./15, Mfd. By-M/s. UltratechParmaceuticals,(An ISO 9001:2000 & GMP Certified Company) Vill.Tipra, P.O.:Barotiwala, Distt.Solan (H.P.)

Assay of Clotrimazole and Lignocaine Hydrochloride RDTL/629/13-14
Date:- 25-07-14

CDSCO, Sub-Zone, Chandigarh
RDTL, Chandigarh
20
FLUCONAZOLE CAPSULES (FLZ-150)

Batch No – CE1106                            D/Mfg.    ­– 10/2012, D/Exp.    – 10/2015, Mfd. By- M/s. GRACURE PHARMACEUTICALS LTD., Bhiwadi,  (Raj)
Uniformity of filled weight & Dissolution RDTL/885/13-14 Date:- 22-07-14

CDSCO, North Zone
RDTL, Chandigarh
21
Maxclave 625 (Amoxycillin&Clavulanate Potassium tablets IP)
Batch No –MLT-033,                             D/Mfg. -07/2013, D/Exp. – 12/2014, Mfd. By- M/s. MaxmedLifesciencesPvt Ltd., Plot-No. 5, Sec. IIDC, Sidcul, Rudrapur (Uttarakhand)
Assay of Clavulanic Acid
CDSCO, Goa
CDTL, Mumbai

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