Actavis Laboratories, FL, Inc. recalls Metformin Hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratori
Recalled October 21, 2015 · FDA recall D-0014-2016 · Actavis Laboratories, FL
Hazard
Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint. · FDA Class II
Units
13,284 bottles
Sold at
Nationwide and Puerto Rico
Description
Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint.
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.
Manufacturer(s)
Actavis Laboratories, FL, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →