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Class III · Lower riskRecall completed

Bleomycin

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

Does this affect you?
Check your lot numberBL0018
Where it was soldUSA nationwide
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

Labeling: Not elsewhere classified: Mislabeling

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 byThymoorgan Pharmazie GmbH Schiffgraben 23, 38690 Gosfar, Germany Distributed by Hikma USA Inc. Berkeley Heights, NJ 07922 foreign manufacturer
Brand nameBLEOMYCIN
Generic nameBLEOMYCIN
Active ingredient(s)BLEOMYCIN SULFATE
Distributed by / forHikma USA Inc. Berkeley Heights, NJ 07922
NDC0143-9240-01
Show the full FDA record
Full product labelBleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx only, Manufactured by Thymoorgan Pharmazie GmbH Schiffgraben 23, 38690 Gosfar, Germany Distributed by Hikma USA Inc. Berkeley Heights, NJ 07922, NDC 0143-9240-01
Recalling firmHikma Pharmaceuticals USA Inc.
DistributionUSA nationwide
Quantity1,152 vials
Recall initiated2021-08-05
Report date2021-09-01
Recall completed2023-06-08
Recall numberD-0771-2021
ClassificationClass III
FDA statusTerminated
Origin on fileCherry Hill NJ United States

Related

Recent drug recallsCheck another medication

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.