Drug & medication recalls Moderate risk

Actavis Laboratories, FL, Inc. recalls Metformin Hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laborator…

Recall date
September 25, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0014-2016
FDA classification
Class II
Brand / firm
Actavis Laboratories, FL, Inc.
Sold / distributed
Nationwide and Puerto Rico

Why it was recalled

Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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