Recall: D-0925-2023

Class II - Potentially Harmful

Class IIClassification

2023-07-11Initiated

OngoingStatus

Ascend Laboratories, LLCFirm

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

Failed Dissolution Specifications

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.