Class II
Terminated
Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 00591-2720-60
- Company
- Teva Pharmaceuticals Usa, Inc
- Recall Initiated
- February 22, 2023
- Posted
- March 15, 2023
- Recall Number
- D-0441-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 12,044 Bottles
- Firm Location
- Parsippany, NJ, United States
Reason for Recall
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Distribution
CA
Lot / Code Info
Lot #: 1410946A; Exp. 06/2023
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