FDA recall D-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.

Reason for recall

Failed Dissolution Specifications

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2023-07-11

Report date

2023-07-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0925-2023