The Recall Desk
LowFDA (Drugs)·D-0771-2021·Announced 2021-09-01

Bleomycin for Injection Recalled Due to Mislabeling

Hikma Pharmaceuticals USA Inc. is recalling Bleomycin for Injection, USP due to mislabeling. The recall affects 1,152 vials distributed nationwide.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall for a mislabeling issue with no reported illnesses or injuries. Mislabeling without evidence of patient harm is considered a labeling or documentation issue, which corresponds to a Low severity rating per the rubric.

Plain-English summary

Hikma Pharmaceuticals USA Inc. is recalling Bleomycin for Injection, USP (NDC 0143-9240-01) due to a mislabeling issue. The affected product consists of 1,152 vials with lot code BL0018, each containing 15 units per single dose vial.

The product is manufactured by Thymoorgan Pharmazie GmbH (Schiffgraben 23, 38690 Gosfar, Germany) and distributed by Hikma Pharmaceuticals USA Inc. (Berkeley Heights, NJ 07922). The recall applies to distribution nationwide.

Bleomycin for Injection is a prescription-only drug administered via intramuscular, intrapleural, intravenous, or subcutaneous routes. Healthcare providers and patients who have received this product should contact Hikma Pharmaceuticals USA Inc. for further guidance.

The recalled product

Product
BLEOMYCIN (BLEOMYCIN)
Brand
BLEOMYCIN
Manufacturer
Hikma Pharmaceuticals USA Inc.
Category
Drug — Prescription Injectable
Hazard
  • mislabeling

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • BL0018

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · BLEOMYCIN

Same category