FDA Drug Class II — Moderate

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.

Hazard

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

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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
Brand
Actavis Laboratories, FL, Inc.
UPC
Lot: 1037736A, Exp 03/18

Units Affected

13,284 bottles

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