FDA Recall D-0925-2023
Ascend Laboratories, LLC · Parsippany, NJ
Class II Ongoing 1038 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
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
Recall record
- Recall number
D-0925-2023- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA
- Recall initiated
- 2023-07-11
- Classified by FDA Center
- 2023-07-18
- FDA published
- 2023-07-26
- Recalling firm
- Ascend Laboratories, LLC
- Firm location
- Parsippany, NJ
Drug identification
- Brand name(s)
- FINGOLIMOD
- Generic name(s)
- FINGOLIMOD HYDROCHLORIDE
- Manufacturer(s)
- Ascend Laboratories, LLC
- NDC(s)
67877-476- Route(s)
- ORAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.