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Class II: temporary or reversible health riskOngoing

Ascend Laboratories Fingolimod Capsules Recall

Fingolimod Capsules, 0

Ascend Laboratories, LLC · Parsippany, NJ

Risk level
Class II
Reported by FDA
Jul 26, 2023
Recall ID
D-0925-2023
Check your lot numberHow we source this data

Summary

Ascend Laboratories recalled Fingolimod Capsules starting Jul 11, 2023. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0925-2023 on Jul 26, 2023. Reason: Failed Dissolution Specifications. Status: Ongoing.

Why it was recalled

Failed Dissolution Specifications

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.

Lot numbers, UPCs & expiration codes

Lot 22122841, Exp August 2025

Where it was sold

Nationwide in the USA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0925-2023
Classification
Class II
Status
Ongoing
Recall initiated
Jul 11, 2023
FDA report date
Jul 26, 2023
Quantity
2652 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Ascend Laboratories, LLC

Original FDA data

Every field from FDA enforcement report D-0925-2023, exactly as published.

Show all FDA fields
City
Parsippany
State
NJ
Status
Ongoing
Country
United States
Event ID
92667
Address
339 Jefferson Rd Ste 101
Code information
Lot 22122841, Exp August 2025
Postal code
07054-3707
Report date
Jul 26, 2023
Product type
Drugs
Recall number
D-0925-2023
Classification
Class II
Recalling firm
Ascend Laboratories, LLC
Product quantity
2652 bottles
Reason for recall
Failed Dissolution Specifications
Voluntary / mandated
Voluntary: Firm initiated
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.
Distribution pattern
Nationwide in the USA
Recall initiation date
Jul 11, 2023
Initial firm notification
Letter
Center classification date
Jul 18, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0925-2023, published Jul 26, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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