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Class III · Lower riskRecall completed

Azacitidine

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot: FE22001A, Exp 01/2024
Where it was soldDistributed in Ohio
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

Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.

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 byBluePoint Laboratories
Brand nameAZACITIDINE
Generic nameAZACITIDINE
Active ingredient(s)AZACITIDINE
Distributed by / forTeva Pharmaceuticals USA Inc
NDC68001-313-56
Show the full FDA record
Full product labelAzacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56
Recalling firmTeva Pharmaceuticals USA Inc
DistributionDistributed in Ohio
Quantity4162 cartons
Recall initiated2022-07-22
Report date2022-08-17
Recall completed2023-04-12
Recall numberD-1334-2022
ClassificationClass III
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.