Class III · Low risk
Bleomycin for Injection
Labeling: Not elsewhere classified: Mislabeling
Bleomycin for Injection
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of particulate matter: glass
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop vial, Rx Only, Distributed by: Hospira, Inc., Lake Forest, IL 68045, NDC 61703-332-18
Affected NDC
61703-0332-18
Compare with the code on your package — it is the most precise check available.
Drug: Bleomycin
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Bleomycin NDC 61703-0332 |
SULFATE 15 [USP'U]/1 | Injection, Powder, Lyophilized, for Solution Intramuscular|intrapleural|intravenous|subcutaneous |
Hospira, Inc. | Rx |
- Recalling firm
- Pfizer
- NDC code
- 61703-332-18
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0261-2024 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week.
Other Bleomycin recalls
See all
Class II · Moderate risk
Bleomycin 18 Units / 100 Ml Ns Ivpb
Lack of Assurance of Sterility
Class II · Moderate risk
Bleomycin Sulfate 1unit/ml
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
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Class II · Moderate risk
Vial Label: 8.4% Sodium Bicarbonate Injection
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Class II · Moderate risk
Vial Label: Epinephrine Injection
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Levoxyl (levothyroxine sodium tablets, USP)
Subpotent drug
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