D-0925-2023 Class II Ongoing

Recalled by Ascend Laboratories, LLC — Parsippany, NJ

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