Recalls / Class II
Class IID-0925-2023
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.
- Brand name
- Fingolimod
- Generic name
- Fingolimod Hydrochloride
- Active ingredient
- Fingolimod Hydrochloride
- Route
- Oral
- NDC
- 67877-476
- FDA application
- ANDA208004
- Affected lot / code info
- Lot 22122841, Exp August 2025
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Ascend Laboratories, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 339 Jefferson Rd Ste 101, N/A, Parsippany, New Jersey 07054-3707
Distribution
- Quantity
- 2652 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-07-11
- FDA classified
- 2023-07-18
- Posted by FDA
- 2023-07-26
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0925-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.