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Class II · ModerateRecall completed

Alprazolam

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot # EH8348, exp. date August 2023
Where it was soldProduct was distributed 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 dissolution test results observed.

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

Made byMylan Pharmaceuticals Inc.
Brand nameALPRAZOLAM
Generic nameALPRAZOLAM
Active ingredient(s)ALPRAZOLAM
Distributed by / forGreenstone LLC, Peapack, NJ 07977
NDC59762-0068-1
Show the full FDA record
Full product labelalprazolam XR extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-0068-1.
Recalling firmViatris Inc
DistributionProduct was distributed nationwide in the USA
Quantity6,789 bottles
Recall initiated2022-04-28
Report date2022-05-11
Recall completed2023-06-21
Recall numberD-0844-2022
ClassificationClass II
FDA statusTerminated
Origin on fileCanonsburg PA 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.