FDAFDA · Food and drugs·Recall number D-0099-2019
Metformin Hydrochloride Extended Release Tablets, 500 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories, FL Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 00591-2411-01
Published October 31, 2018 · Recall initiated: August 6, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Teva Pharmaceuticals USA
- Distributor
- Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.
- Lot
- Lot #: 1210888A, Exp 03/2019
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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