PlainRecalls
FDA Drug Moderate Class II Terminated

Metoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 62037-831-01

Reported: October 31, 2018 Initiated: October 19, 2018 #D-0129-2019

Product Description

Metoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 62037-831-01

Reason for Recall

Failed dissolution specifications: Out-of-Specification dissolution test result obtained during routine stability testing.

Details

Recalling Firm
Teva Pharmaceuticals USA
Units Affected
53,451 bottles
Distribution
U.S.A. Nationwide including Puerto Rico.
Location
North Wales, PA

Frequently Asked Questions

What product was recalled?
Metoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 62037-831-01. Recalled by Teva Pharmaceuticals USA. Units affected: 53,451 bottles.
Why was this product recalled?
Failed dissolution specifications: Out-of-Specification dissolution test result obtained during routine stability testing.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 31, 2018. Severity: Moderate. Recall number: D-0129-2019.