Drug Alert: CDSCO Flags 45 Formulations As Not Of Standard Quality
New Delhi: In its latest drug safety alert, the apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) flagged 45 medicine batches for failing to qualify a random drug sample test for the month of August, 2022.
This came in line with the list of drugs, medical devices and cosmetics declared as Not of StandardbQuality/Spurious/Adulterated/Misbranded for the Month of August – 2022.
These drugs samples which are declared not of standard quality include Dispersible Amoxycillin Tablets I.P. 125 mg manufactured by Caplet India, Oflopac-OZ Tablet (Ofloxacin & Ornidazole Tablet I.P.) manufactured by Amkon Pharmaceuticals, Domperidone Tablets manufactured by Karnataka Antibiotics & Phamacetucials, Iron Sucrose Injection U.S.P. manufactured by Maan Pharmaceuticals and others.
Furthermore, other popular drug samples that are declared not of standard quality include Eris Lifesciences Limited' Velgut (Prebiotic & Probiotic Capsules), Boehringer Ingelheim India Private Limited's Ondero Met 2.5mg /500 mg (Fixed Dose Combination of Linagliptin and Metformin Hydrochloride Tablets), Theon Pharmaceuticals' Theozole (Itraconazole Capsules BP 100 mg) and etc.
Apart from this, few batches of Teneligliptin Tablets I.P. 20mg (ZITEN) manufactured by Glenmark Pharmaceuticals and Sertraline Tablets I.P. 50 mg manufactured by Skymap Pharmaceuticals are on the list.
This came after analysis and tests conducted by the CDSCO Drugs Control Department on 1330 samples. Out of these, 1285 samples were found to be of standard quality while 45 of them were declared as Not of Standard Quality (NSQ).
A few of the reasons why the drug samples tested failed were the failure of the assay, failure of the dissolution test, failure of sterility test, failure of Alpha Lipoic Acid, Methylcobalamin and Vitamin D3 etc.
The samples collected were tested in six laboratories, namely CDL Kolkata, CDTL Mumbai, RDTL Chandigarh and RDTL Guwahati, CDTL Hyderabad, CDTL Chennai.
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of August – 2022.
Total number of samples tested | 1330 |
Total number of samples declared as of Standard Quality | 1285 |
Total number of samples declared as Not of Standard Quality | 45 |
Total number of samples declared as Spurious | - |
Total number of samples declared as Misbranded | - |
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. | Methylcobalamin and Alpha Lipoic Acid Capsules | B. No.: 28021831 Mfg dt: 04/2021 Exp dt: 02/2023 Mfd by: M/s. USV Private Limited Plot No. 6 & 7E, HPSIDC Indl. Area, Baddi, Dist.: Solan, Himachal Pradesh- 173205. | Description and Assay of Alpha Lipoic Acid | CDSCO Sub Zone Guwahati | RDTL Guwahati |
2. | Primaquine Phosphate Tablets I.P. 2.5 mg. | B. No.: TP-980001 Mfg dt: 12/2020 Exp dt: 11/2022 Mfd by: M/s. Centurion Remedies Pvt. Ltd., G- 5 & G-6, Industrial Estate, Gorwa, Vadodara- 390016, Gujarat. | Assay | CDSCO Sub Zone Guwahati | RDTL Guwahati |
3. | Paracetamol Tablets I.P. 500 mg. | B. No.: TGT05212515 Mfg dt: 05/2021 Exp dt: 04/2023 Mfd by: M/s. T & G Medicare, Village Kunjahal PO-Baddi Dist. Solan, Himachal Pradesh. | Dissolution | Drug Control Department Assam | RDTL Guwahati |
4. | Paracetamol Tablets IP 650 mg. (DOL-P*650) | B. No.: PRT - 938 Mfg dt: 05/2021 Exp dt: 04/2023 Mfd by: M/s. ALCO FORMULATION | Dissolution | Drug Control Department Assam | RDTL Guwahati |
(INDIA), 14/5, Mathura Road, Faridabad- 121003, Haryana. | |||||
5. | Ciprofloxacin & Tinidazole Tablets Cipkon-TZ | B. No.: RT-007 Mfg dt: 09/2020 Exp dt: 08/2022 Mfd by: M/s. RIKON PHARMACEUTICALS PVT. LTD. Unit at: D-6, Phase-III, Indl. Area, Fatuha. (India), Bihar. | Assay | Drug Control Department Bihar | RDTL Guwahati |
6. | (PRICON) Sterile Single Use Hypodermic Needle | B. No.: 38GB0621070 Mfg dt: 06/2021 Exp dt: 05/2024 Mfd by: M/s. ISCON SURGICALS LTD., B- 70, M.I.A., Phase II, Basni, Jodhpur 342 005 (INDIA), Rajasthan. | Sterility | Drug Control Department Rajasthan | RDTL Guwahati |
7. | Primaquine Tablets I.P. 7.5 mg. | B. No.: 191134 Mfg dt: 11/2019 Exp dt: 10/2022 Mfd by: M/s. Modi Antibiotics, Plot No. 28, G.I.D.C. Estate, Odhav, Ahmedabad – 382 415 GUJARAT. | Assay | CDSCO Sub Zone Guwahati | RDTL Guwahati |
8. | Levocetirizine | B. No.: 21112704 | Dissolution of | CDSCO | RDTL |
Dihydrochloride and | Mfg dt: 05/2021 | Montelukast | Sub Zone | Guwahati | |
Montelukast Sodium | Exp dt: 04/2023 | Guwahati | |||
Tablets IP | Mfd by: M/s. | ||||
MERCURY | |||||
LABORATORIES LTD. | |||||
Unit No. 2, Halol- | |||||
Baroda Road, Village: | |||||
Jarod, Tal: Waghodia, | |||||
Dist: Vadodara- | |||||
391510, Gujarat. | |||||
9. | Pantoprazole | B. No.: POF-01 | Assay | Drug Control | RDTL |
Sodium Tablets IP | Mfg dt: 10/2021 | Department | Guwahati | ||
40mg. | Exp dt: 09/2023 | Assam | |||
Mfd by: M/s. Applied | |||||
Communication & |
Controls, Khasra No. 122, Selaqui Industrial Area, Dehradun, Uttarakhand – 248 011. | |||||
10. | Chlordiazepoxide 5 | B. No.: D2050026 | Assay of | Drug Control | RDTL |
mg & Amitriptyline | Mfg dt: 12/2020 | Chlordiazepoxide | Department | Guwahati | |
Hydrocholoride | Exp dt: 11/2023 | Bihar | |||
12.5mg Tablets | Mfd by: M/s. | ||||
USP Libotryp | WOCKHARDT | ||||
LIMITED Plot No. 57, | |||||
Village Kunjhal P.O. | |||||
Barotiwala Teh, | |||||
Nalagarh, Distt. Solan, | |||||
Himachal Pradesh - | |||||
174103. | |||||
11. | Ivermectin Tablets USP | B. No.: PT0031 Mfg dt: 05/2021 | Dissolution | Drug Control Department | RDTL Guwahati |
Exp dt: 04/2023 | Arunachal | ||||
Mfd by: M/s. OMEGA | Pradesh | ||||
PHARMA, Khasra No. | |||||
482, Village- Saliyar, | |||||
Roorkee- 247667, | |||||
Distt. Haridwar, | |||||
Uttarakhand. | |||||
12. | Amoxycillin & | B. No.: MBT22020 | Dissolution of | CDSCO | RDTL |
Potassium | Mfg dt: 03/2022 | Potassium | Sub Zone | Guwahati | |
Clavulanate Tablets | Exp dt: 08/2023 | Clavulanate | Guwahati | ||
IP (DEMOXYCLAV) | Mfd by: M/s. Mediwell | ||||
Biotech, Plot No. 21- | |||||
22, Phase-IV, Himuda | |||||
Industrial Township, | |||||
Bhatolikalan, Baddi, | |||||
Dist. Solan, Himachal | |||||
Pradesh – 173205. | |||||
13. | Vitamin D3 | B. No.: MUTBC2101 | Description | Drug Control | RDTL |
Chewable Tablets | Mfg dt: 07/2021 | Department | Guwahati | ||
60,000 IU | Exp dt: 06/2023 | Meghalaya | |||
Mfd by: M/s. MAXTAR | |||||
BIO-GENICS, Khasra | |||||
No. 705, Vill. Malku | |||||
Majra, Nalagarh Road, | |||||
Baddi, Distt. Solan- | |||||
173205, Himachal |
Pradesh – India. | |||||
14. | Norfloxacin Tablets IP | B. No.: NOR-2001 Mfg dt: 01/2021 Exp dt: 12/2022 Mfd by: M/s. RIDLEY LIFE SCIENCE PVT. LTD. D-1651, DSIDC, Indl Complex, Narela, Delhi-110040. | Dissolution | Drug Control Department Meghalaya | RDTL Guwahati |
15. | CEFADROXIL TABLETS I.P. 500 mg | B. No.: T2072 Mfg dt: 03/2022 Exp dt: 02/2024 Mfd by: M/s. ZEST PHARMA Plot No. 275, Sector 'F' Sanwer Road, Indore - 452 015, Madhya Pradesh. | Dissolution | Drug Control Department Assam | RDTL Guwahati |
16. | Norfloxacin Tablets IP Ridnor-400 | B. No.: RID-1925 Mfg dt: 02/2020 Exp dt: 01/2023 Mfd by: M/s. RIDLEY LIFE SCIENCE PVT. LTD. D-1651, DSIDC Indl. Complex, Narela, Delhi- 110040. | Dissolution | Drug Control Department Assam | RDTL Guwahati |
17. | Dispersible Amoxycillin Tablets I.P. 125 mg | B. No.: AXT 11072 Mfg dt: 12/2021 Exp dt: 11/2023 Mfd by: M/s. Caplet India Pvt. Ltd., Works: Rekjuani, Rajarhat , Kolkata - 700 135. | Uniformity of Dispersion | CDSCO East Zone Kolkata | CDL Kolkata |
18. | Oflopac-OZ Tablet (Ofloxacin & Ornidazole Tablet I.P.) | B. No.: APNT/206 Mfg dt: 04/2022 Exp dt: 03/2024 Mfd by: M/s. Amkon Pharmaceuticals Pvt. Ltd., Plot No. 253, Phase-IX, Industrial Area, S.A.S. Nagar, Mohali-160062 Punjab. | Identification & Assay | CDSCO East Zone Kolkata | CDL Kolkata |
19. | CANZON (Ciprofloxacin | B. No.: 21006 Mfg dt: 03/2021 | Dissolution | CDSCO East Zone | CDL Kolkata |
Tablets I.P. 500 mg) | Exp dt: 02/2024 Mfd by: M/s. Diamond Drugs Pvt. Ltd., A.T. Ghosh Road, Jagacha, Howrah -711112, Kolkata. | Kolkata | |||
20. | Domperidone Tablets I.P. 10 mg | B. No.: 3100221 Mfg dt: 05/2021 Exp dt: 04/2024 Mfd by: M/s. Karnataka Antibiotics & Phamacetucials Limited, Plot No. 14, II Phase, Peenya, Bengaluru - 560 058, Karnataka. | Related Substances | CDSCO East Zone Kolkata | CDL Kolkata |
21. | Iverzest 12 (Ivermectin Dispersible Tablets 12 mg) | B. No.: PNT3940D Mfg dt: 05/2021 Exp dt: 04/2023 Mfd by: M/s. Plena Remedies, Plot No. 17, Industrial Area (Himuda), Bhatoli Kalan, Baddi, Distt. Solan, Himachal Pradesh- 173205. | Uniformity of Dispersion | CDSCO East Zone Kolkata | CDL Kolkata |
22. | Iron Sucrose Injection U.S.P. 5 ml | B. No.: ISI21019 Mfg dt: 05/2021 Exp dt: 04/2023 Mfd by: M/s. Vivek Pharmachem (India) Ltd., NH-8, Chimanpura, Amer, Jaipur-303102, Rajasthan. | Particulate Matter | CDSCO East Zone Kolkata | CDL Kolkata |
23. | Paracetamol Tablets I.P. 650 mg | B. No.: BTPM110 Mfg dt: 09/2021 Exp dt: 08/2023 Mfd by: M/s. ANG Lifesciences India Ltd., Vill. Malkumajra, Nalagarh Road, Baddi, Distt. Solan 173 205, Himachal Pradesh. | Dissolution | CDSCO East Zone Kolkata | CDL Kolkata |
24. | Domperidone Tablets I.P. 10 mg | B. No.: 2110138 Mfg dt: 10/2021 Exp dt: 09/2023 Mfd by: M/s. Adroit Pharmaceuticals Pvt. Ltd., 46, Garoba Maidan, Nagpur – 440 008, Maharashtra. | Related Substances | CDSCO South Zone | CDL Kolkata |
25. | Mymi D (Alpha Lipoic Acid, Pyridoxine Hydrochloride Methylcobalamin Folic Acid & Vitamin D3 Tablets) | B. No.: TT22002 Mfg dt: 03/2022 Exp dt: 02/2024 Mfd by: M/s. Kausikh Therapeutics (P) Ltd., Unit II, Plot No. 54 SIDCO Industrial Estate, Thirumudivakkam, Chennai 600 044, Tamil Nadu. | Assay of Alpha Lipoic Acid, Methylcobalamin and Vitamin D3 | CDSCO South Zone | CDL Kolkata |
26. | Metsodoz – 4 Tablets (Methylprednisolone Tablets IP 4 mg) | B. No.: GFM02 2102 Mfg dt: 08/2021 Exp dt: 07/2023 Mfd by: M/s. Progressive Lifesciences Pvt. Ltd., Latherdevahoon, P.O. Jhabrera, Roorkee, Distt. Haridwar – 247 665, Uttarakhand. | Assay | CDSCO South Zone | CDL Kolkata |
27. | Mymifer (Ferrous Ascorbate and Folic Acid Suspension) | B. No.: LT21008 Mfg dt: 10/2021 Exp dt: 03/2023 Mfd by: M/s. Kausikh Therapeutics (P) Ltd., Unit II, Plot No. 54, SIDCO Industrial Estate, Thirumudivakkam, Chennai - 600044. | Assay of Folic Acid | CDSCO South Zone | CDL Kolkata |
28. | RL – 500 ml, Compound Sodium Lactate Injection IP (Ringer Lactate Solution for Injection) | B. No.: 112036 Mfg dt: 12/2021 Exp dt: 11/2023 Mfd by: M/s. Ives Drugs (India) Pvt. Ltd., | Sterility | Drug Control Department Odisha | CDL Kolkata |
Works: Ghatabillod, Dist. Dhar, H.O.: 504, Chetak Center, R.N.T. Marg, Indore -1, India. | |||||
29. | RL – 500 ml, Compound Sodium Lactate Injection IP (Ringer Lactate Solution for Injection) | B. No.: S2FBV33 Mfg dt: 02/2022 Exp dt: 01/2024 Mfd by: M/s. Swaroop Pharmaceuticals Pvt. Ltd., A-10, Tala Nagari Industrial Area, Aligarh - 202 001, Uttar Pardesh. | Bacterial endotoxins | Drug Control Department Odisha | CDL Kolkata |
30. | RL – 500 ml, Compound Sodium Lactate Injection IP (Ringer Lactate Solution for Injection) | B. No.: S2FBV24 Mfg dt: 02/2022 Exp dt: 01/2024 Mfd by: M/s. Swaroop Pharmaceuticals Pvt. Ltd., A-10, Tala Nagari Industrial Area, Aligarh - 202 001, Uttar Pardesh. | Bacterial endotoxins & Sterility | Drug Control Department Odisha | CDL Kolkata |
31. | Iron Sucrose Injection U.S.P. | B. No.: IS20043 Mfg dt: 10/2020 Exp dt: 09/2022 Mfd by: M/s. Maan Pharmaceuticals Ltd., Plot – 1, G.I.D.C. Phase -II, Modhera Road, Mehsana, Gujarat, India. | Particulate Matter and Assay of Iron | CDSCO Ahmedabad | CDL Kolkata |
32. | Sertraline Tablets I.P. 50 mg | B. No.: GM20105 Mfg dt: 11/2020 Exp dt: 10/2022 Mfd by: M/s. Skymap Pharmaceuticals Pvt. Ltd., B-3, Devbhoomi Industrial Estate, Puhana, Iqbalpur Road, Roorkee – 247 667, Uttarakhand. | Dissolution | CDSCO Ahmedabad | CDL Kolkata |
33. | Velgut (Prebiotic & Probiotic Capsules) | B. No.: GVGC22003 Mfg dt: 02/2022 Exp dt: 07/2023 | Assay | CDSCO Guwahati | CDL Kolkata |
Mfd by: M/s. Eris Lifesciences Limited, Amingaon, North Guwahati, Dist. Kamrup – 781 031, Assam. | |||||
34. | Cotton Gauze Absorbent (Non- Sterilized) | B. No.: G-022 Mfg dt: 11/2021 Exp dt: 10/2023 Mfd by: M/s. Durga Surgical Corporation, P.O. Delhi Road, Fazilpur, Sonepat – 131 001, India. | Width | CDSCO Ahmedabad | CDL Kolkata |
35. | Gentamicin Injection I.P. (Vet) – 30 ml | B. No.: VGTA-108A Mfg dt: 12/2021 Exp dt: 11/2023 Mfd by: M/s. Pushkar Pharma, Bhandariwala, Kheri, Kala-Amb, 173 030, Himachal Pradesh. | Description and Particulate Matter | Drug Control Department Himachal Pradesh | CDL Kolkata |
36. | Ondero Met 2.5mg /500 mg (Fixed Dose Combination of Linagliptin and Metformin Hydrochloride Tablets) | B. No.: C99671 Mfg dt: 03/2021 Exp dt: 08/2022 Mfd by: M/s. Boehringer Ingelheim India Private Limited, Building No. D-5, Gala No. 1 to 5, Shree Arihant Compound, Ground Floor, Reti Bunder Road, Kalher, Bhiwandi -15, Thane Z5, Bhiwandi, Maharashtra (India) 421302. | Dissolution, active ingredient degradation and Assay of Linagliptin | CDSCO Sub - Zone Bangalore | CDL Kolkata |
37. | Theozole (Itraconazole Capsules BP 100 mg) | B. No.: GC210453 Mfg dt: 06/2021 Exp dt: 05/2023 Mfd by: M/s. Theon Pharmaceuticals Ltd., | Dissolution | CDSCO Ahmedabad | CDTL Mumbai |
Vill. Saini Majra, Tehsil Nalagarh, Dist. Solan, Himachal Pradesh – 174101. | |||||
38. | Sodonate-500 (Sodium Bicarbonate Tablets USP 500 mg) | B. No.: PNT5806 Mfg dt: 12/2021 Exp dt: 11/2023 Mfd by: M/s. Plena Remedies. Plot no.-17 Industrial Area (Himuda), Bhatoli Kalan, Baddi, Distt. Solan,Himachal Pradesh -173205. | Assay and Uniformity of dosage units | CDSCO West-Zone | CDTL Mumbai |
39. | Gentamicin Injection IP (GERAGEN INJECTION) | B. No.: V2211749 Mfg dt: 05/2022 Exp dt: 04/2024 Mfd by: M/s. B.M.Pharmaceuticals 47-48, Ind. Area, Phase-II, Chandigarh- 160002. | Bacterial Endotoxins and Sterility | CDSCO Sub - Zone Baddi | RDTL Chandigarh |
40. | Ursodeoxycholic Acid Tablets IP 300 mg (BAKLIV-300 TABLETS) | B. No.: TF2037A Mfg dt: 06/2022 Exp dt: 05/2024 Mfd by: M/s. Navkar Lifesciences WHO- GMP Certified Company Plot No. 76, Lodhi Majra, Industrial Area, Baddi, Distt. Solan, Himachal Pradesh. | Identification A, Identification B and Assay | CDSCO Sub - Zone Baddi | RDTL Chandigarh |
41. | Mefenamic Acid and Paracetamol Tablets (MEFIGESIC FORTE TABLETS) | B. No.: TD2030B Mfg dt: 04/2022 Exp dt: 03/2024 Mfd by: M/s. Navkar Lifesciences WHO- GMP Certified Company Plot No. 76, Lodhi Majra, Industrial Area, Baddi, Distt. Solan, Himachal Pradesh. | Assay of Mefenamic Acid | CDSCO Sub - Zone Baddi | RDTL Chandigarh |
42. | Rabeprazole Sodium and Domperidone Tablets (RAYBEPOLL-D TABLETS) | B. No.: MT-211153 Mfg dt: 10/2021 Exp dt: 09/2023 Mfd by: M/s. Matins Healthcare Plot No- 10, Sector-5, I.I.E. Sidcul, HARIDWAR- 249402, Uttarakhand. | Assay of Rabeprazole Sodium | Drug Control Department Leh U.T. Ladakh | RDTL Chandigarh |
43. | TENELIGLIPTIN TABLETS I.P. 20mg (ZITEN®) | B. No.: 18211147 Mfg dt: 12/2021 Exp dt: 11/2023 Mfd by: M/s. Glenmark Pharmaceuticals Ltd. Samlik Marchak, Industrial Growth Centre East Sikkim, Sikkim- 737135. | Dissolution | CDSCO Port office, Visakhapatnam | CDTL Hyderabad |
44. | Ciprofloxacin Tablets IP 500 mg | B. No.: CPT22004 Mfg dt: 05/2022 Exp dt: 04/2024 Mfd by: M/s. Vivek Pharmachem (India) Ltd.,NH-8, Chimanpura, Amer, Jaipur-303102, Rajasthan. | Dissolution | CDSCO South - Zone | CDTL Chennai |
45. | Aluminium Hydroxide, Magnesium Trisilicate and Activated Polydimethylsiloxan e Suspension (Liquid Antacid) | B. No.: 010122-BTN13 Mfg dt: 01/2022 Exp dt: 12/2023 Mfd by: M/s. Biogenetic Drugs Pvt. Ltd., Vill - Jharmazri, Baddi –174103, Dist. Solan, Himachal Pradesh. | Assay | CDSCO South - Zone | CDTL Chennai |
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