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Class I · Most seriousRecall completed

Anagrelide Capsules USP

A reasonable chance it could cause serious harm or death.

Does this affect you?
Check your lot numberLot # GD01090, Exp 05/2022
Where it was soldDistributed Nationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Distributed by / forTeva Pharmaceuticals USA Inc
NDC0172-5241-60
Show the full FDA record
Full product labelAnagrelide Capsules USP, 0.5 mg, 100-count bottles, Rx Only, Manufactured in India For: TEVA PHARMACEUTICALS USA, Inc., North Wales, PA 19454. NDC 0172-5241-60.
Recalling firmTeva Pharmaceuticals USA Inc
DistributionDistributed Nationwide in the USA
Quantity4224 cartons
Recall initiated2022-05-11
Report date2022-06-08
Recall completed2024-02-26
Recall numberD-0992-2022
ClassificationClass I
FDA statusTerminated
Origin on fileParsippany NJ United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.