Class II
Terminated
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
- Company
- Granules Pharmaceuticals Inc.
- Recall Initiated
- December 30, 2024
- Posted
- January 15, 2025
- Recall Number
- D-0192-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 6,804 bottles
- Firm Location
- Chantilly, VA, United States
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
Distributor in OH.
Lot / Code Info
Lot #: 4911311A, Exp. Date: 11/2025
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