FDA-Drug2015-10-21Class II
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.
Actavis Laboratories, FL, Inc.
Hazard
Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint.
Sold states
Nationwide and Puerto Rico
Affected count
13,284 bottles
Manufactured in
4955 Orange Dr, N/A, Davie, FL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0014-2016Don't want to check this manually?
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