D-0192-2025 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 15, 2025
- Initiation Date
- December 30, 2024
- Termination Date
- January 15, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,804 bottles
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.
Distribution Pattern
Distributor in OH.
Code Information
Lot #: 4911311A, Exp. Date: 11/2025