FDA recall D-0014-2016

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.

Reason for recall

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

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2015-09-25

Report date

2015-10-21

Termination date

2017-04-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Davie, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0014-2016