Metformin Hydrochloride Extended-Release Tablets recall: Failed Dissolution
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.
Why was Metformin Hydrochloride Extended-Release Tablets recalled?
Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: 1037736A, Exp 03/18
- Product
- 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.
- Recalling firm
- Actavis Laboratories, FL, Inc.
- Quantity
- 13,284 bottles
- Distribution
- Nationwide and Puerto Rico
- Recall date
- October 21, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)