September 2014

Annexure
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard
Quality/Spurious/Adulterated/Misbranded, For the Month of September, 2014
Sl.
No.
1
2
3
4
5
6
7
Name of
Drugs/medica
l
device/cosmet
ics
Paracetamol
Syrups
Paracetamol
Syrups
Paracetamol
Syrups
Paracetamol
Syrups
Paracetamol
Syrups
Paracetamol
Syrups
Paracetamol
Syrups
Batch No./Date of
Manufacture/Date of
Expiry/Manufactured By
B. No. 448,
D/Mfg. Apr, 2014 ,
D/Exp. Mar, 2016,
Mfg. By.
M/s Brahma Pharmaceuticals,
Dist. Kokrajhar, Pin. 783370
Assam.
B. No. 454,
D/Mfg. May, 2014 ,
D/Exp. May, 2016,
Mfg. By.
M/s Brahma Pharmaceuticals,
Dist. Kokrajhar, Pin. 783370
Assam.
B. No. 446,
D/Mfg. Apr, 2014 ,
D/Exp. Mar, 2016,
Mfg. By.
M/s Brahma Pharmaceuticals,
Dist. Kokrajhar, Pin. 783370
Assam.
B. No. 444,
D/Mfg. Apr, 2014 ,
D/Exp. Apr, 2016,
Mfg. By.
M/s Brahma Pharmaceuticals,
Dist. Kokrajhar, Pin. 783370
Assam.
B. No. 455,
D/Mfg. May, 2014 ,
D/Exp. Apr, 2016,
Mfg. By.
M/s Brahma Pharmaceuticals,
Dist. Kokrajhar, Pin. 783370
Assam.
B. No. 461,
D/Mfg. May, 2014 ,
D/Exp. Apr, 2016,
Mfg. By.
M/s Brahma Pharmaceuticals,
Dist. Kokrajhar, Pin. 783370
Assam.
B. No. 442,
D/Mfg. Apr, 2014 ,
D/Exp. Mar, 2016,
Mfg. By.
M/s Brahma Pharmaceuticals,
Dist. Kokrajhar, Pin. 783370
Assam.
Reason for
failure with
Report No.
(in Form-13)&
Date
Misbranded
Report No.
09616/2014-15
Dated
04-09-2014
Drawn By
CDSCO, East
Zone
From
RDTL,
Guwahati
Misbranded
Report No.
09614/2014-15
Dated
03-09-2014
CDSCO, East
Zone
Misbranded
Report No.
09615/2014-15
Dated
04-09-2014
CDSCO, East
Zone
Misbranded
Report No.
09613/2014-15
Dated
03-09-2014
CDSCO, East
Zone
Misbranded
Report No.
09617/2014-15
Dated
04-09-2014
CDSCO, East
Zone
Misbranded
Report No.
09618/2014-15
Dated
04-09-2014
CDSCO, East
Zone
Misbranded
Report No.
09626/2014-15
Dated
05-09-2014
CDSCO, East
Zone
RDTL,
Guwahati
RDTL,
Guwahati
RDTL,
Guwahati
RDTL,
Guwahati
RDTL,
Guwahati
RDTL,
Guwahati
8
9
10
11
12
13
14
15
Paracetamol
Syrups
Paracetamol
Syrups
Paracetamol
Syrups
Paracetamol
Syrups
Paracetamol
Syrups
Rabcam-20
Tablets
Paracetamol
Syrups
Paracetamol
Syrups
B. No. 445,
D/Mfg. Apr, 2014 ,
D/Exp. Mar, 2016,
Mfg. By.
M/s Brahma Pharmaceuticals,
Dist. Kokrajhar, Pin. 783370
Assam.
B. No. 449,
D/Mfg. May, 2014 ,
D/Exp. Apr, 2016,
Mfg. By.
M/s Brahma Pharmaceuticals,
Dist. Kokrajhar, Pin. 783370
Assam.
B. No. 456,
D/Mfg. May, 2014 ,
D/Exp. May, 2016,
Mfg. By.
M/s Brahma Pharmaceuticals,
Dist. Kokrajhar, Pin. 783370
Assam.
B. No. 447,
D/Mfg. Apr, 2014 ,
D/Exp. Mar, 2016,
Mfg. By.
M/s Brahma Pharmaceuticals,
Dist. Kokrajhar, Pin. 783370
Assam.
B. No. 450,
D/Mfg. May, 2014,
D/Exp. Apr, 2016,
Mfg. By.
M/s Brahma Pharmaceuticals,
Dist. Kokrajhar, Pin. 783370
Assam.
B. No. RAB-078,
D/Mfg. Nov, 2013 ,
D/Exp. Oct, 2015,
Mfg. By.
M/s Regent Ajanta Biotech,
86-87, Vill. MakhiyaliDundi,
Peerpura Road, Roorkee,
Uttarakhand.
B. No. 458,
D/Mfg. May, 2014 ,
D/Exp. Apr, 2016,
Mfg. By.
M/s Brahma Pharmaceuticals,
Dist. Kokrajhar, Pin. 783370
Assam.
B. No. 453,
D/Mfg. May, 2014 ,
D/Exp. May, 2016,
Mfg. By.
M/s Brahma Pharmaceuticals,
Dist. Kokrajhar, Pin. 783370
Assam.
Misbranded
Report No.
09624/2014-15
Dated
04-09-2014
CDSCO, East
Zone
Misbranded
Report No.
09623/2014-15
Dated
04-09-2014
CDSCO, East
Zone
Misbranded
Report No.
09625/2014-15
Dated
05-09-2014
CDSCO, East
Zone
Misbranded
Report No.
09627/2014-15
Dated
05-09-2014
CDSCO, East
Zone
Misbranded
Report No.
09622/2014-15
Dated
04-09-2014
CDSCO, East
Zone
Misbranded
Report No.
09628/2014-15
Dated
04-09-2014
CDSCO, East
Zone
Misbranded
Report No.
09621/2014-15
Dated
04-09-2014
CDSCO, East
Zone
Misbranded
Report No.
09630/2014-15
Dated
05-09-2014
CDSCO, East
Zone
RDTL,
Guwahati
RDTL,
Guwahati
RDTL,
Guwahati
RDTL,
Guwahati
RDTL,
Guwahati
RDTL,
Guwahati
RDTL,
Guwahati
RDTL,
Guwahati
16
17
18
19
20
21
22
23
PD-MET-F
Suspension
RAYZOLE
TABLETS
NET-N-Clean
Bleaching
Powder
Handloom
Cotton Rolled
Bandage
(Non-Sterile)
Bleaching
Powder
ROXYRAB
SUSPENSIO
N
Calcijoint
Tablets
Rey Flam
Tablets
B. No. PMF-09,
D/Mfg. May, 2014,
D/Exp. Apr, 2016,
Mfg. By.
M/s Pharm Asia Drugs,
20-21 Panchal Compound,
Survey No. 78/1,
PatwariHalke No. 17, New
45, Indore.
B. No. BNT-13033
D/Mfg. Mar, 2014,
D/Exp. Aug, 2015,
Mfg. By.
M/s BROSE ENTERPRISE,
160, Nalhera, Anantpur,
Iqbalpur Road, Roorkee,
Uttarakhand-247668.
B. No. (K) 383,
D/Mfg. May, 2014,
D/Exp. Oct, 2016,
Mfg. By.
M/s Repacked By-Bajrang
Chemicals,
Barasat, Kolkata, West
Bengal.
B. No. 033,
D/Mfg. Dec, 2013,
D/Exp. NIL,
Mfg. By.
NIL.
Misbranded
Report No.
09643/2014-15
Dated
09-09-2014
CDSCO, East
Zone
Misbranded
Report No.
09711/2014-15
Dated
25-09-2014
CDSCO, East
Zone
Misbranded
Report No.
09698/2014-15
Dated
25-09-2014
CDSCO, East
Zone
Misbranded
Report No.
RDTL/09/
2014-15
Dated
25-09-2014
CDSCO, East
Zone
B. No. 593,
D/Mfg. Apr, 2014,
D/Exp. NIL,
Mfg. By.
M/s National Chemical &
Perfumery Works,
Fatasil, Guwahati-781009.
B. No. RAB-132
D/Mfg. Apr, 2014,
D/Exp. Mar, 2016,
Mfg. By.
M/s Regent Ajanta Biotech,
86-87, Vill. MakhiyaliDundi,
Peer Pura Road, Roorkee,
Uttarakhand-247807.
B. No. 13A-049,
D/Mfg. Jan, 2013,
D/Exp. Dec, 2014,
Mfg. By.
M/s Unix Biotech,
Jharmajri, Baddi, Dist. Solan173205, Himachal Pradesh.
B. No. RAB-105,
D/Mfg. Apr, 2014,
D/Exp. Mar, 2016,
Mfg. By.
M/s Regent Ajanta Biotech,
86-87, Vill. MAkhiyaliDundi,
Peerpura Road, Roorkee,
Misbranded
Report No.
RDTL/08/
2014-15
Dated
25-09-2014
CDSCO, East
Zone
Misbranded
Report No.
09718/2014-15
Dated
29-09-2014
CDSCO, East
Zone
Disintegration
Report No.
09606/2014-15
Dated
02-09-2014
CDSCO, East
Zone
Disintegration,
Assay
Report No.
09607/2014-15
Dated
02-09-2014
CDSCO, East
Zone
RDTL,
Guwahati
RDTL,
Guwahati
RDTL,
Guwahati
RDTL,
Guwahati
RDTL,
Guwahati
RDTL,
Guwahati
RDTL,
Guwahati
RDTL,
Guwahati
Uttarakhand, 247667.
24
25
26
27
28
29
30
Oflowin-OZ
Tablets
Norfloxacin
Tablets
Metronidazole
Benzoate Oral
Suspensions
Paracetamol
Tablets
Ofloxacin&Or
nidazole
Suspensions
R-Panta 40
Tablets
AMPIRAB-C
CAPSULES
B. No. ABG4003BT,
D/Mfg. Feb, 2014,
D/Exp. Jan, 2016,
Mfg. By.
M/s BHC Lab (P) Ltd.,
91/2, DIC Baddi, Dist. Solan,
173205, Himachal Pradesh.
B. No. 210414,
D/Mfg. Apr, 2014,
D/Exp. Mar, 2016,
Mfg. By.
M/s Veejay Laboratories,
EPIP Zone, Amingaon,
Guwahati-781031, Assam.
B. No. MS/1405,
D/Mfg. Jun, 2014,
D/Exp. May, 2016,
Mfg. By.
M/s Viva Pharma Pvt. Ltd.,
Jorhat, Assam.
Disintegration
Report No.
09642/2014-15
Dated
09-09-2014
CDSCO, East
Zone
Dissolution
Report No.
09639/2014-15
Dated
09-09-2014
CDSCO, East
Zone
Assay
Report No.
09620/2014-15
Dated
04-09-2014
CDSCO, East
Zone
B. No. PKT-3027SB,
D/Mfg. Sep, 2013,
D/Exp. Aug, 2016,
Mfg. By.
M/s Shiva Biogenetic
Pharmaceuticals Pvt. Ltd.,
Vill. Manpura, Baddi, Dist.
Solan, 174101, Himachal
Pradesh.
B. No. DOSL-006,
D/Mfg. Aug, 2013,
D/Exp. Jul, 2015,
Mfg. By.
M/s Laborate
Pharmaceuticals India Ltd.,
Rajban Road, Nariwala,
Paonta Sahib, Himachal
Pradesh.
B. No. RAB-0123
D/Mfg. Nov, 2013,
D/Exp. Oct, 2015,
Mfg. By.
M/s Regent Ajanta Biotech,
86-87, Vill. MakhiyaliDundi,
Peer Pura Road, Roorkee,
Uttarakhand-247807.
B. No. RAB-117
D/Mfg. Apr, 2014,
D/Exp. Mar, 2016,
Mfg. By.
M/s Regent Ajanta Biotech,
86-87, Vill. MakhiyaliDundi,
Peer Pura Road, Roorkee,
Uttarakhand-247807.
Dissolution, Assay
Report No.
09666/2014-15
Dated
15-09-2014
CDSCO, East
Zone
Assay
Report No.
09683/2014-15
Dated
22-09-2014
CDSCO, East
Zone
Dissolution
Report No.
09714/2014-15
Dated
26-09-2014
CDSCO, East
Zone
Assay
Report No.
09717/2014-15
Dated
29-09-2014
CDSCO, East
Zone
RDTL,
Guwahati
RDTL,
Guwahati
RDTL,
Guwahati
RDTL,
Guwahati
RDTL,
Guwahati
RDTL,
Guwahati
RDTL,
Guwahati
31
Hemsyl
Injection
(Etamsylate
Injection),
B. No.: HAA1J32, Mfgdt:
10/2013,
Description &
Particulate
Matter32-8/2014SS/DCA(E)217/1466Dt.
26.09.2014
CDSCO, East
Zone
CDL, Kolkata
Expdt: 10/2014
CDSCO,
North Zone,
Ghaziabad,
UP
CDL, Kolkata
Mfgdt: 11/2012
Constituted
Solution &
Particulate Matter
32-1/2014-SS/
CDSCO, Sub
Zone
Chandigarh
CDL, Kolkata
CDSCO, Sub
Zone
Chandigarh
CDL, Kolkata
CDSCO, Sub
Zone
Chandigarh
CDL, Kolkata
Expdt: 09/2016
Mfd by: M/s. Indoco
Remedies Ltd., L-32, Verna
Industrial Area, Verna, Goa403722
32
33
34
Polytaz 1.125
Injection
(Ceftriaxone
&Tazobactum
for Injection),
C-Zone Plus
1.5 gm
(Ceftriaxone
&Sulbactum
for Injection),
Bupivacaine
Heavy
(Bupivacaine
Hydrochloride
& Dextrose
Injection USP)
B. No.: P-1211105
Mfd by: M/s. Brooks
Laboratories Ltd., Village:
Kashipura, Nalagarh Road,
Baddi 174101, HP
DCA(N)-70/1449
B. No.: PCZ - 109
Mfgdt: 01/2014,
Clarity of Solution
& Particulate
Matter
Expdt: 12/2015
32-18/2014-SS/
Dt. 25.09.2014
Mfd by: M/s. Marc
Laboratories Ltd. (U-III), Plot
No. 112, HPSIDC, Baddi,
Solan (HP).
DCA(C)-47/1448
B.No: I-3864,
Description,
Particulate Matter,
Assay of
Bupivacaine,
Assay of Dextrose
Mfgdt: 05/2013
Expdt: 04/2015
Mfd by: M/s. Jackson
Laboratories Pvt. Ltd., Bye
Pass, Majitha Road, Amritsar
143 004.
Dt. 25.09.2014
32-18/2014-SS/
DCA(C)-04/1406
Dt. 12.09.2014
35
Meparin 5
(Heparin
Sodium) 1000
IU/ml
Solution for
Injection 5 ml,
B.No: N-3176
Description &
Particulate Matter
Mfgdt: 07/2013
32-18/2014-SS/
Expdt: 07/2016
DCA(C)-18/1266
Mfd by: M/s. Medchem
International Ltd., A6,
Banjara Garden, Road No.
12, Banjara Hills, Hyderabad
– 500 034, India
Dt. 02.09.2014
36
Lozep 0.5
(Clonazepam
tabs IP 0.5mg)
B.No: AA-1456
Related
Substances
Mfgdt: 01/2013
CDSCO,
SubZone
Bangalore
CDL, Kolkata
CDSCO,
SubZone
Bangalore
CDL, Kolkata
CDSCO,
Zonal Office
Hyderabad
CDL, Kolkata
32-13/2014-SS/
Expdt: 12/2015
DCA(B)-98/1431
Mfd by: M/s. Psychotropics
India Ltd., Plot No. 46 & 49,
Sector 6A, IIE, SIDCUL
Industrial Area, Ranipur,
Haridwar – 249 403.
37
Amoxicillin
Dispersible
Tablets 250
mg
B. No.: 131103
Dt. 17.09.2014
Uniformity of
Dispersion
Mfgdt: Not Stated
32-13/2014-SS/
Expdt: 01/2016
DCA(B)-52/1297
Mfd by: M/s. Not Stated
Dt. 04.09.2014
38
Carbamine
(Diethylcarba
mazine Citrate
Tablets IP
100mg),
B. No.: FO12016
Description
Mfgdt: 10/2012,
32-12/2014-SS/
Expdt: 09/2014
DCA(H)126/1347
Mfd by: M/s. Ortin
Laboratories Ltd., 275 & 278
(Part), IDA, Pashamilaram
502 307, Medak, AP
39
Ezelax
(Bisacodyl
Tablet I.P.)
B. No.: ZT-8663
Mfgdt: 02/2013,
Expdt: 01/2015
Dt. 08.09.2014
Does not conform CDSCO, West
to IP standard with Zone
respect to the test
for Disintegration
CDTL,
Mumbai
Does not conform
to specification
with respect to the
test for PH
CDTL,
Mumbai
Mfd by: M/s. Zee
Laboratories, 47 Industrial
Area, Paonta Sahib173025
40
Pafenil 150
(Paracetamol
Injection 2ml)
B. No.: 13AD82
Mfgdt: 04/2013,
Expdt: 03/2015
CDSCO, West
Zone
Mfd by: M/s.
Pharmafabrikon, Unit-II, 91-1
SivagangaiRaod, Vilathur,
Madurai-625020
41
B.No: 10023-BG137
Ibuprofen
Tablets IP 400
mg
Regn.No:CDTL/Form18/D/0394/14-15
Mfd. Dt: Feb- 2013
Exp. Dt: Jan - 2016
Does not conform
with respect to
Test For
Dissolution
CDTL,
Chennai
CDSCO,
Zonal Office,
Hyderabad
MfdBy: Biogenetic Drugs
Pvt.Ltd, Jharmazri Baddi-174
103,
Dist-Solan HP
42
Dispersible
Amoxycillin
Tablets I.P
(ANTEMOX250 DT)
Batch No.-T5266 D/Mfg.Dec. 2013 D/Exp.-Nov. 2015
Mfd. By – M/s Jackson
Laboratories Pvt. Ltd.,
Amritsar Majitha Road, Bye
Pass, Amritsar-143004
Uniformity of
Dispersion, Report
No.
LSD/RDTL/0120/
14-15
CDSCO. Sub
Zone,
Chandigarh
RDTL
Chandigarh
43
Ciprofloxacin
e
Hydrochloride
Tablets I.P
(CIPMARX500)
Batch No. - CPT-4514,
D/Mfg.-Jun. 2013, D/Exp.May. 2015 Mfd. By – M/s
A.K. Biotech Pvt. Ltd.,
Export Promotional Industrial
Park, Kartholi Jammu181133
Dissolution &
Assay Report No.
LSD/RDTL/0211/
14-15
CDSCO. Sub
Zone,
Chandigarh
RDTL
Chandigarh
44
Ofloxacin&Or
nidazole
Tablets
(Floxavin-OZ)
Batch No. - FZ-28, D/Mfg.Apr. 2014 D/Exp.-Sep. 2015
Mfd. By – M/s Therawin
Formulation 69-71, Jasmeet
Nagar, Ambala City-134007
Disintegration
Test Report No.
LSD/RDTL/0263/
14-15
CDSCO. Sub
Zone,
Chandigarh
RDTL
Chandigarh
45
Paracetamol,
Diclofenac
sodium
&Serratiopepti
dase Tablets
(Lyser DP
Tablets)
Batch No.-B142008, D/Mfg.May. 2014, D/Exp.-Apr.
2016, Mfd. By – M/s Comed
Chemicals Limited., Village
Dassomajra, P.O. Bhud.
Baddi, Tehsil Nalagarh, Solan
(H.P)
Assay of
Serratiopeptidase
Report No.
LSD/RDTL/0213/
14-15
CDSCO. Sub
Zone,
Chandigarh
RDTL
Chandigarh

Download Report