Class II
Ongoing
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.
This recall is currently active, issued July 26, 2023. It was issued by Ascend Laboratories, Llc.
- Company
- Ascend Laboratories, Llc
- Recall Initiated
- July 11, 2023
- Posted
- July 26, 2023
- Recall Number
- D-0925-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2652 bottles
- Firm Location
- Parsippany, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Dissolution Specifications
Distribution
Nationwide in the USA
Lot / Code Info
Lot 22122841, Exp August 2025
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