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NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF SEPTEMBER– 2024.
B. State Laboratories
S.No Product/Drug Batch No. Manufacturing Expiry Manufactured By NSQ Result Reported by
Name Date Date CDSCO Laboratory
1. Neurotem-NT CPT-2698 Mar-24 Feb-26 Catasta Pharmaceuticals The given Drug Drug Testing Laboratory
Plot No. 113, DIC, Sample does Srinagar (J&K) vide
Industrial Area, Baddi Distt. not comply to report on Form 13
Solan (H.P) the contents of bearing No. L/DA/2024-
Mrk. By : Cosway Assay with 25/1191
Biosciences Coprporate respect to Dated: 05.09.2024.
Office : Khasra No. Pregabalin ( (Report attached as
2054/1724, 1725 SCO No. 23.26% of Annexure A)
11 Baddi Barotiwala Road claim)
The. Baddi Distt. Solan H.P
173205
2. Cefuroxime Axetil JAK-23 Jul-23 Jun-25 Agron Remedies Pvt Ltd The sample Combined Food & Drug
Tablets IP 500 mg Sarverkhera Moradabad fails in the Testing Laboratory
(JKMSCL Supply) Road Kashipur 244 713 Description, Jammu (J&K) vide
(Uttarakhand) Dissolution and report on Form 13
Assay of bearing No.
Cefuroxime CFDL/J/2024-25/1120
Axetil w.r.t the Dated: 26.09.2024.
sample portion (Report attached as
received as Annexure B)
above
3. Loperamide T-16201 May-24 Apr-26 Karnani Pharmaceuticals The sample Drug Testing
Hydrochloride Pvt. Ltd , 38 Pharma City , does not Laboratory Srinagar
Tablets IP Selaqui Dehradun -248011 conform to IP (J&K) vide report on
(JKMSCL Hospital with respect to Form 13 bearing No.
Supply) the test for L/DA/2024-25/1311
Dissolution & Dated: 27.09.2024.
Assay (Report attached as
Annexure C)4. Floxages-OZ SPY41223 12/23 11/26 Suraksha Pharma pvt.Ltd, It fails the test Drugs Testing
(Ofloxacin and 410, Karondi, Roorkee-247 ‘Dissolution’ as Laboratory
Ornidazole Tablets 667, Uttarakhand per IP Thiruvananthapuram
IP)
5. Wintel 40 Tablets H T N257D 04/24 03/26 Himalaya Meditek pvt.Ltd, It fails the test Drugs Testing
Plot No. 35 & 36, ‘Dissolution’ as Laboratory
Pharmacity, Selaqui, per IP Thiruvananthapuram
Industrial Area, Dehradun -
248 197
6. Moxica -250 SD 243 08/23 07/25 Indica Pharmaceuticals (P) It fails the test Drugs Testing
[Amoxicillin Ltd, Bapunagar, ‘Disintegration’ Laboratory
Dispersible Tablets Ahmedabad- 382 345 and ‘Uniformity Thiruvananthapuram
IP 250 mg] of Dispersion’
specified in the
Laboratory
Protocol as per
IP
7. Frusemide Injection FRIB-03 01/24 12/25 Nestor Pharmaceuticals It fails the test Drugs Testing
IP 20 mg Ltd, 11, Western Extension ‘Sterility’ as per Laboratory
Area, Faridabad -121001 IP Thiruvananthapuram
8. Cloxacillin Sodium CLCA-04 04/23 03/25 Nestor Pharmaceuticals The sample Drugs Testing
Capsules IP 250 Ltd, 11, Western Extension does not Laboratory
mg Area, Faridabad -121001 conform to IP Thiruvananthapuram
Standards with
respect to
‘Descriptive part’
of hard gelatin
capsules and
further tests
cannot be
performed due
to reasons
secified in the
laboratory
protocol
9. Fluorometholone CHE-3044 05/23 04/25 Cotec Healthcare pvt.Ltd, It fails the test Drugs Testing
Eye Drops IP K.H.No.593/1, Roorkee, ‘Uniformity of Laboratory
Dehradun Highway, Volume’ and ThiruvananthapuramKishanpur, Roorkee- 247 ‘Assay’ as per
667, UK IP
10. Panlib 40 Tablets H T N 102A 01/24 12/25 Himalaya Meditek pvt.Ltd, It fails the test Drugs Testing
Plot No. 35 & 36, Dissolution’ and Laboratory
Pharmacity, Selaqui, ‘Assay’ as per Thiruvananthapuram
Industrial Area, Dehradun IP
11. B - Cidal 625 U T232859 03/24 08/25 VADSP Pharmaceuticals, The content of Drugs Testing
Plot No. 124, EPIP Clavulanic acid Laboratory
Indl.Area, Phase 1, is not with in the Thiruvananthapuram
Jharmajri, Baddi (HP)- limit of
174103 ‘Schedule V’ of
Drugs and
Cosmetics Act &
Rules
thereunder
12. Trypsin, Bromelain TTF24065 06/24 11/25 Tiruvision Medcare, Plot The sample fails Drugs Testing
& Rutoside No. 177, HPSIDC, the test Laboratory
Trihydrate Tablets Indl.Area, Baddi, Dist Solan ‘Disintegration’ Thiruvananthapuram
[Flavoshine] HP 173 205 specified in the
Laboratory
protocol as per
IP
13. C Mont LC Kid 60 AL 23206 11/23 10/25 Cian Healthcare Ltd, kh The content of Drugs Testing
ml (Montelukast & No.248, Village sisonia, montelukast is Laboratory
Leveocetirizine Bhagwanpur, Roorkee, not within the Thiruvananthapuram
Dihydrochloride Haridwar, Uttarakhand- 247 limits of
syrup) 661 Schedule ‘V’ of
Drugs &
Cosmetics Act &
Rules
14. Yogaraja Guggulu P 592324 10/23 09/26 Oushadhi, The The sample Drugs Testing
Tablet Pharmaceutical corporation does not Laboratory
(IM) , Kerala Ltd, conform to API Thiruvananthapuram
Kuttanellur, Thrissur- 68 Standards. It
0014 fails the tests
‘Total Ash’ as
per API
Standards.15. Telmisartan Tab IP D1153/24-25 Kerala Medical Services The sample Drugs Testing
40 mg Corporation Ltd, Thycaud does not Laboratory
P.O, Thiruvananthapuram- conform to IP Thiruvananthapuram
14 Standards with
respective to
‘Descriptive part’
of tablets and
further tests
cannot be
performed due
to above
reasons.
16. Pantoprazole Inj.BP D 0923/24- Kerala Medical Services It fails the test Drugs Testing
40 mg 25 Corporation Ltd, Thycaud ‘Sterility’ Laboratory
P.O, Thiruvananthapuram- specified in the Thiruvananthapuram
14 laboratory
protocol as per
IP
17. Glimepiride Tab IP D 1 272/24-25 Kerala Medical Services The sample fails Drugs Testing
Corporation Ltd, Thycaud the descriptive Laboratory
P.O, Thiruvananthapuram- part for tablets Thiruvananthapuram
14 as they are not
sufficiently hard
to withstand
handling without
crumbling or
breaking and
further tests
cannot be
performed due
to above reason
18. Cough Syrup D 1278/24- Kerala Medical Services The sample fails Drugs Testing
25 Corporation Ltd, Thycaud the ‘Descriptive Laboratory
P.O, Thiruvananthapuram- part’ for oral Thiruvananthapuram
14 dosage forms of
Schedule V of
drugs and
cosmetics Act
and Rules, asthe syrup
contains red
coloured
suspended
paticles
NOTE:
1. NSQ data was not received as per Format & in EXCEL SHEET from State Drugs Licensing Authorities of Karnataka (PDF format),
Thiruvanthapuram (Excel format), and Jammu Kashmir (Excel Format) for the Month of August, 2024 as per DCG(I) Circular dated
09.02.2024.
2. State Drugs Licensing Authorities of Andhra Pradesh, Arunachal Pradesh, Assam, Bihar, Chhattisgarh,Goa,Gujarat, Haryana,
Himachal Pradesh, Manipur, Rajasthan, Meghalaya, Mizoram, Nagaland, Odisha, Punjab, Sikkim, Tamil Nadu,
Pondicherry,Telangana,Delhi,Uttarakhand, West Bengal, Andaman & Nicobar, Dadar and Nagar Haveli; Daman and Diu, Lakshadweep
have not submitted any data in respect of the Not of Standard Quality (NSQ) Alert for the Month of August, 2024 as per DCG(I) Circular
dated 09.02.2024.