Recalling firm
Granules Pharmaceuticals Inc.
Product type
Drug
Status
Terminated
Report date
2025-01-15
Distribution
Distributor in OH.
Firm state
VA
Product quantity
6,804 bottles
Initiated by
Voluntary: Firm initiated
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.
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
Code / lot info
Lot #: 4911311A, Exp. Date: 11/2025
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.