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NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF MAY – 2024.
A. CDSCO/Central Laboratories
S.No Name of Batch Date of Date of Manufactured By NSQ Result Reported by
Drugs/medical No. Manufactur Expiry CDSCO Laboratory
device/cosmetics e
1. Terbutaline VS16010 01-01-2024 01-12-2026 Priya Life Science,174-A, The sample does not Central Drugs
Sulfate,Bromhexin 175,Siddhi Industrial conform to Manufacturer's Laboratory, Kolkata
e Hydrochloride Infrastructure Park, Specification with respect
with Guaiphenesin Opp. Waghodia to the Assay of
Syrup GIDC, Waghodia Bromhexine Hydrochloride
and
Terbutaline Sulphate.
2. METOPROLOL GT3J026 01-10-2023 30-09-2025 Scott-Edil The sample does not Central Drugs
SUCCINATE PharmaciaLtd.,56, EPIP., conforms to claim as per Laboratory, Kolkata
EXTENDED Phase-I, I.P.2022inrespectto the
RELEASE Jharmajri,Baddi, Test of Dissolution
TABLETS IP Distt.Solan-173 205, (1Hr),Dissolution(4 Hours)
(H.P.),INDIA
3. Cuftin COUGH ECT- 01-09-2023 31-08-2025 ELFOS The sample does not RDTL , Chandigarh
LINCTUS 2421 LABORATORIES,at conforms to claim as per
:F-54,M.I.Area, JAIPUR- Patent and Proprietary in
17 respect to the Assay of
Sodium Citrate
4. CefuroximeAxetil DB23030 01-12-2023 30-11-2025 Daxin Pharmaceuticals The sample does not Central Drugs
Tablets IP 4 Pvt.Ltd.,PlotNo 121-122 conforms to claim as per IP Laboratory, Kolkata
EPIP, Jharmajri Phase 1, 2022in respect to the Test
Teh. Baddi, Distt. of Dissolution of
Solan (H.P.) - 174103 Cefuroxime Axetil
equivalent to Cefuroxime
5. LevosalbutamolSul 5346 07-03-2024 04-02-2026 Esquire Drug House,138, The sample does not Central Drugs
phate,AmbroxolHC GIDC, Estate,Wadhwan conform to claim as per Laboratory, Kolkata
L,Guaiphenesin City, District Schedule V of Drugs &
Syrup Cosmetics Act with respect
1 | Pa g eSurendranagar 363035 to Assay of
(Gujarat) Levosalbutamol Sulphate
Equivalent to
Levosalbutamol.
NB:The sample does not
give positive test for
Diethylene glycol and is
found to contain 0.0071 %
w/v Ethylene glycol; (Limit
NMT 0.1% w/v, Method:
GC, Ref: USP under the
monograph of Propylene
glycol,)
6. Acetylsalicylic Acid JTN23- 05-07-2023 03-06-2026 AK Krishna Pharma Sample does not conforms Central Drugs
Tablets 75 mg 211 Pvt.Ltd.,Plot No. to IP with respect to test for Laboratory, Kolkata
68, 69 &82,83 Dissolution.
Sector-6A, Sidcul,
IIE, Dist. Haridwar,
Uttarakhand, India.
7. LactuloseSolution GA2312 02-11-2023 07-10-2025 Skymap Pharmaceuticals The sample does not Central Drugs
U.S.P. 7 Pvt. Ltd.,B-3, Dev conforms to claim as per Laboratory, Kolkata
Bhoomi Industrial Estate, U.S.P.in respect to the
PuhanaIqbalpur Road, Assay.
Roorkee-247667
8. Terbutaline 23D-20 01-04-2023 31-03-2025 RADICALS The sample does not RDTL, Chandigarh
Sulphate, PHARMAPVT. LTD.,194, conforms to claim as per
Bromhexine Mile Patent and Proprietary
Hydrochloride, Stone, Ambala- Delhi (RDTL/MS/3286)in
Guaiphenesinand Highway, respect to the Assay of
Menthol Syrup Shahpur,Ambala Cantt- Terbutaline Sulphate,
133 004 Bromhexine
(Hry.) Hydrochloride
9. PRDT- 01-11-2022 31-10-2024 WINGSBIOTECH LLP,43 The sample does not RDTL, Chandigarh
Prednisolone 1007 & 44, conforms to claim as per IP
TabletsIP10mg 2018 and Addendum 2021
2 | Pa g eHPSIDC,Industrial Area, in respect to the Assay of
Baddi - 173205 (H.P.) Prednisolone
10. Mecobalamin, DBIS- 02-11-2023 08-10-2025 Broad Injectables,PlotNo. The sample does not Central Drugs
AlphaLipoicAcid, 8591 51-52, Ind. Area conforms to claim as per Laboratory, Kolkata
Pyridoxine TahliwalDistt. Una Schedule V of Drugs and
Hydrochlorideand 174301 (H.P.) Cosmetics Act with respect
Folic Acid Soft to the Assay/content of
Gelatin Capsules Mecobalamin and
PyridoxineHydrochloride
11. TELMISARTAN TE3016A 01-05-2023 30-04-2025 M/s. The sample received CDTL, Hyderabad
ANDAMLODIPINE NavkarLifesciences,Plot DOES NOT CONFORM
TABLETS IP No. 76, LodhiMajra, toI.P.2022Specification
Industrial Area, Baddi, with respect to the test
Distt. parameters Dissolution
Solan (H.P.) and Assay of Amlodipine
Besylate equivalent to
Amlodipinecontentonly.
CDTLHREPORTNO.:
CDTLH/1510/F-
1068/2023-24
12. Cefoperazone& B- 01-01-2023 02-12-2024 Pace Biotech, Surajpur, The sample does not Central Drugs
Sulbactam for 22680D Paonta Sahib, Dist- conforms to claim as per Laboratory, Kolkata
Injection Sirmour (H.P)- 173001 The Schedule V of The
Drugs and Cosmetics
Act,1940withrespectto the
Test for 'Clarity of solution'
and' Particulate matter'
13. Cefotaxime CTI2308 08-08-2023 07-01-2025 M/s. Vivek Pharmachem The sample does not Central Drugs
InjectionIP500mg 1 (India) Ltd., NH-8, conforms to I.P. with Laboratory, Kolkata
Chimanpura, Amer, respect to the Test for
Jaipur-303 102 INDIA 'Related Substances',
'Particulate matter' and
'Clarity of solution'
3 | Pa g e14. Dexamethasone DSA123 06-07-2023 04-06-2025 M/s Nandani Medical The sample does not Central Drugs
SodiumPhosphate 13 Laboratories Pvt. conforms to IP with respect Laboratory, Kolkata
Injection I.P Ltd.,,221/5,Bicholi Hapsi, to Assay/ content of
Kanadia Road, Indore Dexamethasone
Phosphate
15. Amoxycillin&Potas 23AP04 03-05-2023 02-04-2025 SAI Parenterals The sample does not Central Drugs
sium Clavulanate Limited,,D1&D4, Survey conforms to claim as per Laboratory, Kolkata
InjectionIP1.2gm No.280,Phase-V, IDA, I.P. 2022 in respect to the
Jeedimetla, Hyderabad, Test of Clarity of solution
500055, TS and Assay of Potassium
Clavulanate calculated as
Clavulanic
Acid
16. TELMISARTAN BD23178 01-12-2023 30-11-2025 BIOALTUS NOTE: THE SAMPLE CDTL, Hyderabad
AND 0H PHARMACEUTICA LS RECEIVED DOES NOT
METOPROLOL PRIVATE LIMITED,(A CONFORM TO
SUCCINATE WHO GMP CERTIFIED MANUFACTURERS
(EXTENDED COMPANY) At: 19- SPECIFICATION WITH
RELEASE) 20, DIC, Ind. Area, Baddi, RESPECT TO THE TEST
TABLETS Distt. Solan, (H.P.) FOR DISSOLUTION FOR
173205 THE CONTENT OF
METOPROLOL
SUCCINATE
EQUIVALENT TO
METOPROLOL
TARTRATE(EXTENDED
RELEASE) AT THE FINAL
TEST TIME (20th HOUR)
OF L1+L2+L3 LEVEL
ONLY.
CDTLHREPORTNO.:
CDTLH/1527/F-
17. Pantoprazole PAA-507 01-06-2023 31-05-2025 Healers Lab, Unit II, Plot The sample Does not RDTL, Guwahati
Tablets I.P.. No. 33, H.P.S.I.D.C., complies conforms to
Manufacturer Specification
4 | Pa g eExtn., Baddi, Distt.Solan with respect to the above
(H.P.) tests only.
18. Pantoprazole PAA-507 01-06-2023 31-05-2025 Healers Lab, Unit II,Plot The sample Does not RDTL, Guwahati
Tablets I.P.. No. 33, H.P.S.I.D.C., complies conforms to
Extn., Manufacturer Specification
Baddi,Distt.Solan (H.P.) with respect to the above
tests only.
19. Ambroxol HCl, VDL- 01-07-2022 30-06-2024 VVPB The sample does not RDTL, Chandigarh
Levosalbutamoland 1240 Pharmaceuticals Pvt. conforms to claim as per
Guaiphenesin Ltd.,Kh. No. Patent and Proprietary in
Syrup 114, Vill. respect to the Test of
Damowala, P.O. Diethylene Glycol (DEG)
Barotiwala, Baddi, and Assay of Ambroxol
Distt. Solan (H.P.) Hydrochloride
20. Dexamethasone 323-885 03-08-2023 09-07-2025 ZEE LABORATORIES The sample does not Central Drugs
Sodium Phosphate LTD.,Behind47, Industrial conforms to IP with respect Laboratory, Kolkata
Injection I.P. Area, Paonta Sahib- to test for "Free
(8mg/2ml) 173025 Dexamethasone",
"Particulate matter,",
"Extractable volume"
,"Assay of
Dexamethasone Sodium
Phosphate calculated as
Dexamethasone
Phosphate" and is also
not of standard quality for
the reason stated under
"Description".
21. Dexamethasone DX-2305 05-05-2023 04-04-2025 M/s.Konis The sample does not Central Drugs
Sodiumphosphate Pharmaceuticals, conforms to claim as per Laboratory, Kolkata
Injection IP Krishna Nagar - 522502 IP2022 in respect to the
(A.P.) Test of Description and
Particulate matter
22. Paracetamol 500 PAR-31 01-08-2023 31-07-2026 ASKON HEALTH The sample Does not RDTL, Guwahati
mg. Tablets CARE,11-B, Complies conforms to
5 | Pa g eINDUSTRIAL I.P. with respect to the
AREA, MAXI above tests only.
ROAD,UJJAIN-
456010(M.P.)
23. Ofloxacin AD24059 01-04-2024 31-03-2026 Skymap Pharmaceuticals Note: the sample received CDTL, Hyderabad
Ornidazole Tablets Pvt. Ltd.,(A WHO- does not
IP GMP Certified conformtoi.p.2022
Company)B-3,Dev specification with respect
Bhoomi Industrial Estate, to the test for dissolution
PuhanaIqbalpur Road, for the content of ofloxacin
Roorkee-247667 and ornidazole ( s1, s2 and
s3 level) only. Cdtlh report
no.:
cdtlh/0131/f-
24. Vildagliptinand VMC04G 01-10-2023 30-09-2025 Bajaj Healthcare The sample does not Central Drugs
Metformin 23A Ltd.,R.S.No.1818, conform to IP with respect Laboratory, Kolkata
Hydrochloride Manjusar – Savli Road, to the test for Dissolution
Tablets IP At & Post- Manjusar, Tal. and Assay of Vildagliptin.
50mg/1000mg Savli, Dist.
Vadodara- 391775.
25. Amoxycillin & TCV- 01-03-2023 28-02-2025 Rivpra The sample does not RDTL, Guwahati
Potassium 2303003 FormulationPvt.Ltd.,Plot conform to I.P. with respect
Clavulanate No.8, Sector-6A, I.I.E. to the test for Assay.
Tablets I.P.. SIDCUL, Haridwar- 249
403 (U.K.)
26. Clonazepam 04L23T0 06-12-2023 04-11-2026 M/s. Shine The sample does not Central Drugs
TabletsI.P.0.5mg 3 Pharmaceuticals conforms to claim as per IP Laboratory, Kolkata
Limited,, PlotNo. 132, in respect to
Karjan- Vermardi Road, The Test of Related
Juni Jitherdi, Ta. Substances
Karjan-391240,
Dist: Vadodara,
(Gujarat).
27. Metronidazole TC- 03-03-2023 04-02-2025 Technica Lab & Pharma The sample does not Central Drugs
Extended Release 060323 Pvt.Limited, Plot No. conform to U.S.P with Laboratory, Kolkata
6 | Pa g eTablets USP 600 100, Sector- 7, IIE, respect to the test of
MG SIDCUL ,Haridwar, Dissolution.
Uttarakhand
28. Diclofenac Sodium RCT230 09-06-2023 04-02-2026 Galpha Laboratories The sample does not Central Drugs
and Paracetamol 50 Limited..,Village - Thana, conforms to claim as per IP Laboratory, Kolkata
Tablets IP Baddi, Himachal in respect to the Test of
Pradesh- 173 205.. Description
29. Atropine Sulphate 23UG18 01-07-2023 30-062025 SVP LIFE The sample does not RDTL , Chandigarh
Injection IP SCIENCES,C/10-1 conforms to claim as per
Sara Industrial Estate, IP2022in respect to the
Selaqui, Dehradun Test of pH and Assay of
Atropine Sulphate
30. Montelukast ATA-176 01-02-2023 31-01-2025 Alliaance Biotech,,440/3, The sample does not RDTL, Guwahati
Sodium & Village Katha, Baddi, conform to I.P. with respect
Levocetirizine Distt.Solan (HP) - 173205 to the above tests only.
Hydrochloride
Tablets
31. Fluconazole UGT233 01-03-2023 28-02-2025 Unimark Healthcare Ltd., The sample received does CDTL, Mumbai
Tablets IP (150 38 Plot No.: 24, 25 & 37 not conform to the
mg).. Sector 6 A, SIDCUL, I.P.2022 standard with
Haridwar - 249403 respect to the test for
(Uttarakhand) Related substances.
32. Ceftriaxone 324-166 02-02-2024 07-07-2026 Zee Laboratories The sample does not Central Drugs
Injection I.P Limited,,Behind47, complies to claim as per IP Laboratory, Kolkata
Industrial Area, Paonta 2022in respect of test for
Sahib- 173205. appearance of solution,
clarity of solution,
particulate matter and
sterility
(Powder for Injection).
33. Ramipril & PT- 01-07-2023 01-06-2025 PharmarootsHealthcare, The sample received does CDTL,Mumbai
Hydrochlorthiazide 31954 Khasra No. 411, Village not conform to the
Tablets IP Tipra, P.O. Barotiwala, I.P.2022standardwith
Tehsil Baddi,Distt.Solan, respect to the test for
H.P. assay of Ramipril.
7 | Pa g eNote:-Other test could not
be done due to technical
reason
34. GLIPIZIDEAND 4010026 08-11-2023 03-04-2025 USV Private Limited,At : The sample does not CDL, Kolkata
METFORMIN B- 249/B-250, IInd conform to claim I.P. with
TABLETS IP Stage, Peenya Industrial respect to the test for
Estate, Bangalore-560 Dissolution of Glipizide
058
35. Ceftriaxone for DC3011 05-10-2023 09-09-2025 Captab Biotec, Unit- II, The sample does not CDL, Kolkata
InjectionI.P.1gm 9 Plot No.125, conforms to I.P. with
E.P.I.P. Road, respect to test for
Mauja, Jharmajri, Baddi, "Particulate Matter
Distt. Solan, H.P.
36. Gentamicin 323-216 03-03-2023 05-02-2025 ZEE LABORATORIES The sample does not CDL, Kolkata
Sulphate Injection LTD., Behind 47, Indl. conforms to I.P. with
I.P. 2ml Area, Paonta Sahib- respect to the test for
173025 "Particulate matter" and is
also not of standard quality
for the reason stated under
"Description"
37. Calcium 500 mg LMT240 01-03-2023 28-02-2026 Life Max Cancer The sample Does not RDTL, Guwahati
withVitaminD3250 263 Laboratories , Plot No. Complies conforms to
IU Tablets IP 106 & 106 A, I.P. with respect to the
Sector-6A, IIE, SIDCUL, above tests only.
Haridwar- 249403 (U.K)
38. Cefixime & DB23005 02-02-2023 01-01-2025 Daxin Pharmaceuticals The sample does not CDL, Kolkata
Ofloxacin Tablets 7 Pvt.Ltd.,PlotNo 121-122 conforms to claim as per
EPIP, Schedule V of Drugs &
Jharmajri Phase1, Teh. Cosmetics Act with respect
Baddi, Distt. Solan (H.P.) to the Assay of Cefixime
-174103 Trihydrate eq. to
anhydrous Cefixime
and Assay of Ofloxacin
39. Ceftriaxone C2402- 02-02-2024 05-01-2026 Integrated Laboratories The sample does not Central Drugs
Injection IP 02F Pvt. Ltd., Nahan conform to IP with respect Laboratory, Kolkata
8 | Pa g eRoad. Vill. to the Particulate matter,
Moginand, Kala Amb, Clarity of Solution and for
Distt. Sirmour (H.P.)- the reason stated under
173030 Description
9 | Pa g e