D-0828-2020 Class II Terminated
FDA drug recall D-0828-2020 was initiated by Ascend Laboratories LLC on January 24, 2020 and is designated Class II. Reason for recall: cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement. The recall status is terminated (terminated October 29, 2021). Affected quantity: 192 Bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 12, 2020
- Initiation Date
- January 24, 2020
- Termination Date
- October 29, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 192 Bottles
Product Description
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.
Reason for Recall
cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement.
Distribution Pattern
Nationwide in the U.S.
Code Information
Lot #: 19122552, Exp 7/31/2021