FDAHealthDecember 30, 2024
Granules Pharmaceuticals Inc. — Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules India Limited, Hyderabad- 500 081, India, Manufact
⚠️ 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.
Is this relevant to me?
- Geography
- OH
- Source agency
- FDA
- Category
- Health
- Published
- December 30, 2024
Distributor in OH.
What's affected?
- 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
- Brand
- METFORMIN ER 500 MG
- UPC
- 0382009117102
- Lot code
- 4911311A
Additional details
Lot #: 4911311A, Exp. Date: 11/2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 6,804 bottles.
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