D-0925-2023 Class II Ongoing
FDA drug recall D-0925-2023 was initiated by Ascend Laboratories, LLC on July 11, 2023 and is designated Class II. Reason for recall: Failed Dissolution Specifications The recall status is ongoing. Affected quantity: 2652 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 26, 2023
- Initiation Date
- July 11, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2652 bottles
Product Description
Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-476-30.
Reason for Recall
Failed Dissolution Specifications
Distribution Pattern
Nationwide in the USA
Code Information
Lot 22122841, Exp August 2025