FDA-Drug2023-07-26Class II
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.
Ascend Laboratories, LLC
Hazard
Failed Dissolution Specifications
Sold states
Nationwide in the USA
Affected count
2652 bottles
Manufactured in
339 Jefferson Rd Ste 101, N/A, Parsippany, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0925-2023Don't want to check this manually?
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