CDSCO Flags 14 Drug Samples including Aspirin, Rosuvastatin As Not Of Standard Quality
New Delhi: In its recent drug safety alert, the apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) flagged 14 medicine batches for failing to qualify for random drug sample test for the month of February 2021.
These drug samples including Amoxycillin and Potassium Clavulanate Tablets, Amoxycillin Capsules IP 500 mg, Doxylamine Succinate and Pyridoxine Hydrochloride Tablets, Aspirin Gastro-Resistant Tablets IP 150 mg, Ciprofloxacin Hydrochloride Tablets IP 500 mg and others are declared as Not of Standard Quality.
This came after analysis and test conducted by the CDSCO, Drugs Control Departments, on 1204 drug samples. Out of this, 1190 samples were found of Standard quality while 14 of them were declared as Not of Standard Quality (NSQ).
Failure of the assay, failure of the dissolution test, failure of the Particulate Matter and Clarity of Solution test, failure of the Vitamin B12 Assay, and others were among the reasons why the drug samples tested failed.
The samples collected were tested in three laboratories namely CDL Kolkata, CDTL Mumbai, RDTL Chandigarh.
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of February 2021
Total number of samples tested | 1204 |
Total number of samples declared as of Standard Quality | 1190 |
Total number of samples declared as Not of Standard Quality | 14 |
Total number of samples declared as Spurious | 0 |
Total number of samples declared as Misbranded | 0 |
S. No. | Name of Drugs/medical device/cosmetics | Batch No./Date of Manufacture/Date of Expiry/Manufactured By | Reason for failure | Drawn By | From |
1. | ULGEL – A 200 ml (Magaldrate, Simethicone & Oxetacaine Oral Suspension) | B. No.: 1808001807 Mfg dt: 12/2018 Exp dt: 11/2021 Mfd by: M/s. Alembic Pharmaceuticals Ltd., Samardung Basti, Karek Block, Namthang Ilaka, South Sikkim – 737 126. | Assay of Oxetacaine | CDSCO, North Zone | CDL, Kolkata |
2. | DELSONE-M 16 Tablets (Methylprednisolone Tablets I.P. 16 mg) | B. No.: ART29005 Mfg dt: 11/2019 Exp dt: 10/2021 Mfd by: M/s. Psychotropics India Ltd., Plot No. 46 & 49, Sector- 6A, IIE, SIDCUL, Ranipur, Haridwar-249403 Uttarakhand. | Dissolution | CDSCO, Hyderabad | CDL, Kolkata |
3. | Amoxycillin & Potassium Clavulanate Tablets I.P. 625 mg | B. No.: 0017 Mfg dt: 11/2019 Exp dt: 04/2021 Mfd by: M/s. Stride Organics Private Ltd., Sy. No. 265/P, Kondapur (Vill.), Ghatkesar, Medchal District (T.S.), Telangana. | Dissolution & Assay of Potassium Clavulanate | CDSCO, Hyderabad | CDL, Kolkata |
4. | Cardirid (Carvedilol Tablets IP) | B. No.: CAR-2001 Mfg dt: 06/2020 Exp dt: 05/2022 Mfd by: M/s. Ridley Life Science Pvt. Ltd., D 1651, DSIDC Indl. Complex, Narela, Delhi-110 040. | Uniformity of Content and Related Substances | CDSCO, Hyderabad | CDL, Kolkata |
5. | RAMZE-5 (Ramipril Tablets I.P.) | B. No.: 420-578 Mfg dt: 05/2020 Exp dt: 04/2022 Mfd by: M/s. Zee Laboratories, 47, Industrial Area, Paonta Sahib – 173025 Himachal Pradesh. | Assay | CDSCO, East Zone, Kolkata | CDL, Kolkata |
6. | Theopenam -1g (Meropenem Injection I.P.) | B. No.: MERM19015A Mfg dt: 07/2019 Exp dt: 06/2021 Mfd by: M/s. Theon Pharmaceuticals Ltd., Village Saini Majra, Teh. Nalagarh, Distt. Solan Himachal Pradesh – 174101. | Particulate Matter and Clarity of Solution | CDSCO, East Zone, Kolkata | CDL, Kolkata |
7. | Rosuvas 20 (Rosuvastatin Tablets I.P.) | B. No.: EMX0174 Mfg dt: 01/2020 Exp dt: 06/2022 Mfd by: M/s. Sun Pharma Laboratories Ltd., Plot No. 107-108, Namli Block, P.O. Ranipool, East-Sikkim-737 135. | Uniformity of Weight, Dissolution and Assay | CDSCO, East Zone, Kolkata | CDL, Kolkata |
8. | Amoxycillin Capsules IP 500 mg | B. No.: YAT91054 Mfg dt: 11/2019 Exp dt: 10/2021 Mfd by: M/s. Yeluri Formulations Pvt. Ltd., Sy. No. 296/7/6, I.D.A. Bollaram, Sangareddy, District-502325, Telangana. | Assay | CDSCO, West Zone, Mumbai | CDTL, Mumbai |
9. | Doxylamine Succinate & Pyridoxine Hydrochloride Tablets | B. No.: PF8B101 Mfg dt: 08/2019 Exp dt: 07/2021 Mfd by: M/s. Pure & Cure Healthcare Pvt. Ltd., Plot No. 26A, 27-30, Sector-8A, I.I.E., SIDCUL, Haridwar- 249403, Uttrakhand. | Disintegration Time | CDSCO, West Zone, Mumbai | CDTL, Mumbai |
10. | Prolonged-release Diltiazem Tablets BP 90mg | B. No.: GM20128 Mfg dt: 11/2020 Exp dt: 10/2022 Mfd by: M/s. Skymap Pharmaceuticals Pvt. Ltd., B-3, Dev Bhoomi Industrial Estate, Puhana Iqbalpur Road, Roorkee-247667 Uttarakhand. | Dissolution | CDSCO, West Zone, Mumbai | CDTL, Mumbai |
11. | Revol-CC (Calcium Carbonate Magnesium Oxide, Manganese Sulphate, Zinc & Vitamin D3 Tablets) | B. No.: MT191325 Mfg dt: 08/2019 Exp dt: 07/2021 Mfd by: M/s. Mascot Health Series Pvt. Ltd., Plot No. 79, 80, Sec-6A, IIE, Siducul, Haridwar- 249403, Uttrakhand. | Assay of Vitamin D3 | CDSCO, West Zone, Mumbai | CDTL, Mumbai |
12. | Aspirin Gastro-Resistant Tablets IP 150 mg | B. No.: APET716 Mfg dt: 06/2019 Exp dt: 05/2021 Mfd by: M/s. Unicure India ltd., C-21, 22 & 23, Sector- 3, Noida- 201301, Distt: Gautam Budh Nagar (U.P). | Test for Salicylic Acid | CDSCO, West Zone, Mumbai | CDTL, Mumbai |
13. | Ciprofloxacin Hydrochloride Tablets IP 500 mg | B. No.: 0703419 Mfg dt: 09/2019 Exp dt: 08/2022 Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Limited Plot No. 14, II Phase, Peenaya, Bengaluru- 560058. | Dissolution | CDSCO, North Zone | RDTL, Chandigarh |
14. | Cefpodoxime Proxetil Dispersible Tablets (BROTOCEF-100 DT TABLETS) | B. No.: CT1904E Mfg dt: 12/2019 Exp dt: 11/2021 Mfd by: M/s. J.M. Laboratories Village- Bhanat, P.O. - Ghatti, Subathu Road, Solan Himachal Pradesh- 173211. | Assay | CDSCO, Sub-Zone, Jammu | RDTL, Chandigarh |
To view the official notice, click on the following link:
Also Read: Drug Alert: CDSCO Flags 25 Drugs As Not Of Standard Quality
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