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Serious recall: Injury is possible or has been reported. Take action promptly.

Ascend Laboratories, LLC 2023-07-26 Health serious FDA
Health · FDA · Recall #FDA-D-0925-2023

Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem… Recall

Issued July 26, 2023 · Ascend Laboratories, LLC

In July 2023, Ascend Laboratories, LLC recalled the Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.

Compiled by Dana Whitfield, RecallCheckr

What this means for you

Failed Dissolution Specifications

What you should do

  1. 1 Stop using Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem… right away.
  2. 2 Set it aside where it won't be used by mistake.
  3. 3 Contact Ascend Laboratories, LLC to arrange your voluntary. See the official notice below for contact details.
  4. 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):

Recall details

Brand
Ascend Laboratories, LLC
Category
Health
Recall date
July 26, 2023
Units affected
Not reported
Sold at
Nationwide in the USA
Recall number
FDA-D-0925-2023
Made in
United States
Issuing agency
FDA

In context

  • Ascend Laboratories, LLC has 15 recalls in our database.
  • We're tracking 3,707 Health recalls in our database.
  • This is the 903rd Health recall we've logged in 2023.
Read the official FDA notice

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