CDSCO monthly lab alert

CDSCO NSQ alert, April 2021: 22 drug batches flagged

By Blacklisted editorial team· Published 20 May 2021· Updated 20 Sep 2026· Source: CDSCO NSQ portal

In its April 2021 alert, the Central Drugs Standard Control Organisation listed 22 drug batches that failed quality tests, 20 at central laboratories and 2 at state drug-testing laboratories, from 21 manufacturers across 21 products. The most common failure was dissolution, and the most-represented manufacturing state was Uttarakhand. Products flagged include ZINC SULPHATE DISPERSIBLE TABLETS IP 20 mg, ULTRAFLOX-500 (Ciprofloxacin Tablets I.P.), Tranexamic Acid Tablets IP 250 mg (TYRODIN TABLETS ).

22
Batches flagged
20 / 2
Central / state labs
Dissolution
Top reason
21
Manufacturers

Batches per month, last 12 alerts

May 2020Apr 2021 · 22

Full list of NSQ batches, April 2021

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Product Batch Manufacturer Reason declared NSQ Tested by
ZINC SULPHATE DISPERSIBLE TABLETS IP 20 mg TAC0006ALMfg 2020-06 · Exp 2022-05 Hindustan Laboratories LimitedMaharashtra Disintegration TestDisintegration RDTL GuwahatiCDSCO lab
ULTRAFLOX-500 (Ciprofloxacin Tablets I.P.) 190112AMfg 2019-01 · Exp 2021-12 Bal Pharma LimitedUttarakhand DissolutionDissolution CDL KolkataCDSCO lab
Tranexamic Acid Tablets IP 250 mg (TYRODIN TABLETS ) T0164Mfg 2020-12 · Exp 2022-11 Canixa Life Sciences Pvt. LtdUttarakhand Related SusbtancesOther RDTL ChandigarhCDSCO lab
TRANEXAMIC ACID TABLETS IP T2002047Mfg 2020-02 · Exp 2022-01 Rhydburg Pharmaceuticals LtdUttarakhand Related SubstancesRelated substances RDTL ChandigarhCDSCO lab
TLM-80 (Telmisartan Tablets I.P. 80 mg) 31T20T02Mfg 2020-08 · Exp 2022-07 Shine Pharmaceuticals LimitedGujarat DissolutionDissolution CDL KolkataCDSCO lab
TELMISARTAN TABLETS IP 40 MG CLT-14747Mfg 2020-03 · Exp 2022-02 Caremax FormulationsHimachal Pradesh Uniformity of weight & DissolutionDissolution RDTL ChandigarhCDSCO lab
SPINOBAK-10 (Baclofen Tablets I.P. 10 mg) K3ALT001Mfg 2020-06 · Exp 2022-05 Sirmour Remedies (P) LtdHimachal Pradesh AssayAssay CDL KolkataCDSCO lab
RUTIN (RutosideTrihydra te 95%) (as per F.M) 20181126Mfg 2018-11 · Exp 2021-11 Ningbo Hi-Tech Biochemicals Co Water, Related Substances and AssayAssay CDL KolkataCDSCO lab
REVOL-CC (Calcium Carbonate, Magnesium Oxide, Manganese Sulphate, Zinc & Vitamin D3 Tablets) MT191326Mfg 2019-08 · Exp 2021-07 Mascot Health Series Pvt. LtdUttarakhand Assay of Vitamin D3Assay CDTL MumbaiCDSCO lab
REALHIM-10 (Tadalafil Tablets I.P. 10 mg) LC9L225Mfg 2019-12 · Exp 2021-11 Lifecare Neuro Products LimitedHimachal Pradesh DissolutionDissolution CDL KolkataCDSCO lab
Progesterone Sustained- Release Tablets (FULGEST SR 200 TABLETS) GFSM008Mfg 2019-06 · Exp 2021-05 Synokem Pharmaceuticals LtdUttarakhand DissolutionDissolution RDTL ChandigarhCDSCO lab
Paracetamol Tablets IP 650 mg (MECIPAR 650 TABLETS) SP20641Mfg 2020-07 · Exp 2022-06 Sotac Pharmaceuticals Pvt. LtdGujarat DissolutionDissolution RDTL ChandigarhCDSCO lab
PANTOWEL - 40 (Pantoprazole Sodium Tablets I.P. 40 mg) OBYA01Mfg 2020-02 · Exp 2022-07 Akums Drugs & Pharmaceuticals LtdUttarakhand DissolutionDissolution CDL KolkataCDSCO lab
ORVASTIN-20 (Atorvastatin Tablets IP 20 mg) P-0H0440Mfg 2020-08 · Exp 2023-01 Morepen Laboratories LtdHimachal Pradesh DissolutionDissolution CDTL MumbaiCDSCO lab
OLANZAPINE Tablets I.P. 5 mg T0434Mfg 2020-08 · Exp 2023-07 Bharat Parenterals LtdGujarat DissolutionDissolution CDL KolkataCDSCO lab
MISOPROSTOL Tablets I.P. 200 mcg UHT20096Mfg 2020-07 · Exp 2022-06 Unimark Healthcare LtdUttarakhand AssayAssay CDL KolkataCDSCO lab
L-CETAM 500 (Levetiracetam Tablets I.P. 500 mg) 20S1GTA508Mfg 2020-11 · Exp 2022-10 Synokem Pharmaceuticals LtdUttarakhand DissolutionDissolution CDL KolkataCDSCO lab
INSTANT STERILE MOPPING PAD (Absorbent Gauze- BP Type 13 with X-Ray Detectable Thread) 1017/20Mfg 2020-03 · Exp 2023-02 The Ramaraju Surgical Cotton Mills LtdTamil Nadu Threads per stated lengthOther CDL KolkataCDSCO lab
GLUCORID (Metformin Hydrochloride Sustained Release Tablets I.P. 500 mg) GLU-2009Mfg 2020-08 · Exp 2022-07 Ridley Life Science Pvt. LtdDelhi DissolutionDissolution CDL KolkataCDSCO lab
Chlorhexidine Gluconate and Ethyl Alcohol Antiseptic Solution (CORUB) G-215Mfg 2020-03 · Exp 2022-02 Gag PharmaceuticalsPunjab IdentificationIdentification RDTL ChandigarhState lab
Aceclofenac, Paracetamol and Serratiopeptidase Tablets (ACEPRO-SP TABLETS) SST-0657Mfg 2021-01 · Exp 2022-12 Shri Sai Balaji Pharmatech Pvt. LtdHimachal Pradesh Assay of SerratiopeptidaseAssay RDTL ChandigarhCDSCO lab
70% Isopropyl Alcohol Hand Rub (ICANDY) I010520Mfg 2020-05 · Exp 2022-04 RGG Cosmetics Pvt. Ltd. (Complete address not mentioned on the label) IdentificationIdentification RDTL ChandigarhState lab

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Changelog

  • 20 Sep 2026: table generated from the CDSCO NSQ portal export (22 rows). Revised CDSCO lists are diffed on each monthly rebuild.