Ascend Laboratories LLC recalls Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 4

Recalled February 12, 2020 · FDA recall D-0828-2020 · Ascend Laboratories

Hazard

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

Units

192 Bottles

Sold at

Nationwide in the U.S.

Description

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

Product

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.

Manufacturer(s)

Ascend Laboratories LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →