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.

Recall Number: D-0828-2020

Firm: Ascend Laboratories LLC

Classification: Class II

Status: Terminated

Report Date: 20200212

Initiation Date: 20200124

Termination Date: 20211029

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

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.