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Class II · ModerateRecall completed

PredniSONE Tablets

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

Does this affect you?
Check your lot numberBatch 21P0659
Where it was soldNationwide 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

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

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 byJubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801
Distributed by / forCARDINAL HEALTHCARE
NDC59746-175-06
Show the full FDA record
Full product labelPredniSONE Tablets, USP, 20 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801. NDC: 59746-175-06
Recalling firmCARDINAL HEALTHCARE
DistributionNationwide USA
Quantity1 unit
Recall initiated2022-01-26
Report date2024-01-03
Recall completed2024-09-29
Recall numberD-0193-2024
ClassificationClass II
FDA statusTerminated
Origin on fileDublin OH United States

Related

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.