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
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0441-2023 |
Event ID | 91744 |
Distribution | CA |
Quantity | 12,044 Bottles |
Recall Reason | CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit. |
Drug Classification | Class II |
Drug Code Info | 20230315 |
Recall Initiation Date | 20230222 |
Report Date | 20230315 |
Classification Date | 20230307 |
Address | 400 Interpace Pkwy Bldg A Parsippany, NJ 07054-1120 United States |
Recalling Firm | Teva Pharmaceuticals USA Inc |
Initial Notification | Letter |
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