FDARecalled Jan 15, 2025 · #D-0192-2025
Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules India Limited, Hyderabad- 500 081, India, Manufactured for: Quallent Pharmaceut...
Hazard
Class II — temporary health risk
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Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg. Classification: Class II Distribution: Distributor in OH.
Product details
- Product
- Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules India Limited, Hyderabad- 500 081, India, Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Grand Cayman Islands, NDC 82009-117-10
- Type
- Drugs
- Manufacturer
- Granules Pharmaceuticals Inc.
- Model numbers
- 4911311A
- UPCs
- —