Status
Terminated
Drug Enforcement D-0441-2023
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Classification
Class II
Report Date
March 15, 2023
Termination Date
December 6, 2023
Product Information
- Product 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
- Product quantity
- 12,044 Bottles
- Reason for recall
- CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- CA
Location & Firm
- Recalling firm
- Teva Pharmaceuticals USA Inc
- Address
-
400 Interpace Pkwy Bldg A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0441-2023
- Event ID
- 91744
- Recall initiation date
- February 22, 2023
- Center classification date
- March 7, 2023
- Code info
- Lot #: 1410946A; Exp. 06/2023
- More code info
- —