D-0392-2021 Class III Terminated
FDA drug recall D-0392-2021 was initiated by Ascend Laboratories LLC on April 29, 2021 and is designated Class III. Reason for recall: Presence of Foreign Tablet/Capsule The recall status is terminated (terminated February 17, 2023). Affected quantity: 34296 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- June 2, 2021
- Initiation Date
- April 29, 2021
- Termination Date
- February 17, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 34296 bottles
Product Description
Olmesartan Medoxomil Tablets, USP, 20 mg, Rx Only, 30 Tablets, Manufactured by Alkem Laboratories Ltd, Mumbai, 400 013. INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ, 07054, NDC 67877-446-30.
Reason for Recall
Presence of Foreign Tablet/Capsule
Distribution Pattern
Nationwide
Code Information
Batch No. 20122548, Exp Date: Aug. 2022