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
Reported: March 15, 2023 Initiated: February 22, 2023 #D-0441-2023
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
Reason for Recall
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Details
- Recalling Firm
- Teva Pharmaceuticals USA Inc
- Units Affected
- 12,044 Bottles
- Distribution
- CA
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Teva Pharmaceuticals USA Inc. Units affected: 12,044 Bottles.
Why was this product recalled? ▼
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 15, 2023. Severity: Moderate. Recall number: D-0441-2023.
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