FDA-Drug2025-01-15Class II
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
Granules Pharmaceuticals Inc.
Hazard
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.
Sold states
Distributor in OH.
Affected count
6,804 bottles
Manufactured in
3701 Concorde Pkwy, Chantilly, VA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0192-2025Don't want to check this manually?
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