Recalls / Class II
Class IID-0099-2019
Product
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
- Affected lot / code info
- Lot #: 1210888A, Exp 03/2019
Why it was recalled
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1090 Horsham Rd, N/A, North Wales, Pennsylvania 19454-1505
Distribution
- Quantity
- 3,397 bottles
- Distribution pattern
- Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.
Timeline
- Recall initiated
- 2018-08-06
- FDA classified
- 2018-10-25
- Posted by FDA
- 2018-10-31
- Terminated
- 2020-02-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0099-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.