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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