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.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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
- Affected units
- 1,152
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.
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