Olmesartan Medoxomil Tablets 20 mg recalled over manufacturing violations

Recall date

January 24, 2020

Source

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

Official notice title

Ascend Laboratories LLC recalls Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai -…

Recall number

D-0828-2020

FDA classification

Class II

Brand / firm

Ascend Laboratories LLC

Sold / distributed

Nationwide in the U.S.

Why it was recalled

cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement.

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

What was recalled

Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-446-90.