FDA recall D-0099-2019

Product

Metformin Hydrochloride Extended Release Tablets, 500 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 00591-2411-01

Reason for recall

Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.

Distribution

Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.

Key facts

Status

Terminated

Initiation date

2018-08-06

Report date

2018-10-31

Termination date

2020-02-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Wales, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0099-2019