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.
Recall Number: D-0014-2016
Firm: Actavis Laboratories, FL, Inc.
Classification: Class II
Status: Terminated
Report Date: 20151021
Initiation Date: 20150925
Termination Date: 20170410
Reason for Recall
Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint.
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 0591-2720-60; UPC 3 05912 72060 3.