D-0328-2025 Class II Ongoing
FDA drug recall D-0328-2025 was initiated by Glenmark Pharmaceuticals Inc., USA on March 13, 2025 and is designated Class II. Reason for recall: CGMP Deviations The recall status is ongoing. Affected quantity: N/A.
Recall Details
- Product Type
- Drugs
- Report Date
- April 16, 2025
- Initiation Date
- March 13, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Metformin Hydrochloride Extended-Release Tablets 1000mg, 90-count bottle. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC 68462-521-90.
Reason for Recall
CGMP Deviations
Distribution Pattern
U.S. Nationwide
Code Information
Lot # 17232088, exp. date Sep-25 17232093, exp. date Sep-25