Teva Pharmaceuticals USA recalls Metformin Hydrochloride Extended Release Tablets, 500 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laborator…

Recall date

August 6, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0099-2019

FDA classification

Class II

Brand / firm

Teva Pharmaceuticals USA

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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