Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manuf...
FDA Recall #D-0192-2025 — Class II — December 30, 2024
Product Description
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
Reason for Recall
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.
Recalling Firm
Granules Pharmaceuticals Inc. — Chantilly, VA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
6,804 bottles
Distribution
Distributor in OH.
Code Information
Lot #: 4911311A, Exp. Date: 11/2025
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated