Class II
Terminated
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.
- Company
- Actavis Laboratories, Fl, Inc.
- Recall Initiated
- September 25, 2015
- Posted
- October 21, 2015
- Recall Number
- D-0014-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 13,284 bottles
- Firm Location
- Davie, FL, United States
Reason for Recall
Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint.
Distribution
Nationwide and Puerto Rico
Lot / Code Info
Lot: 1037736A, Exp 03/18
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