Reported Jul 26, 2023 · Ongoing
Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by:…
Ascend Laboratories, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ascend Laboratories, LLC · 339 Jefferson Rd Ste 101 · Parsippany, NJ · 07054-3707
Is this the product you have?
- Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only
- Manufactured byAlkem Laboratories Ltd., INDIA
- Distributed byAscend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-476-30
- Lot codes and dates
Lot 22122841Exp August 2025
- Amount recalled
- 2652 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specifications
This product could cause temporary or reversible health problems — stop using it.
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