FDA recall D-0129-2019

Product

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.

Distribution

U.S.A. Nationwide including Puerto Rico.

Key facts

Status

Terminated

Initiation date

2018-10-19

Report date

2018-10-31

Termination date

2019-04-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Wales, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0129-2019