FDAFDA · Food and drugs·Recall number D-0192-2025
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
Published January 15, 2025 · Recall initiated: December 30, 2024
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Brand
- METFORMIN ER 500 MG
- Manufacturer
- Granules Pharmaceuticals Inc.
- Distributor
- Distributor in OH.
- UPC
- 0382009117102
- Lot
- Lot #: 4911311A, Exp. Date: 11/2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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