Recalls / Class II
Class IID-0014-2016
Product
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 0591-2720-60; UPC 3 05912 72060 3.
- Affected lot / code info
- Lot: 1037736A, Exp 03/18
Why it was recalled
Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint.
Recalling firm
- Firm
- Actavis Laboratories, FL, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4955 Orange Dr, N/A, Davie, Florida 33314-3902
Distribution
- Quantity
- 13,284 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2015-09-25
- FDA classified
- 2015-10-13
- Posted by FDA
- 2015-10-21
- Terminated
- 2017-04-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0014-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.