Product Safety Recalls

Product Recall Tracker

Recall D-0441-2023

Description: 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

Recall D-0441-2023 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0441-2023
Event ID91744
Quantity12,044 Bottles
Recall ReasonCGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Drug ClassificationClass II
Drug Code Info20230315
Recall Initiation Date20230222
Report Date20230315
Classification Date20230307
Address400 Interpace Pkwy Bldg A
Parsippany, NJ 07054-1120
United States
Recalling FirmTeva Pharmaceuticals USA Inc
Initial Notification Letter
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