Recalls / Class I
Class ID-0261-2024
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
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
- Brand name
- Bleomycin
- Generic name
- Bleomycin
- Active ingredient
- Bleomycin Sulfate
- Route
- Intramuscular, Intrapleural, Intravenous, Subcutaneous
- NDCs
- 61703-323, 61703-332
- FDA application
- ANDA065031
- Affected lot / code info
- Lot #: BL12206A, Exp date 06/30/2024
Why it was recalled
Presence of particulate matter: glass
Recalling firm
- Firm
- PFIZER
- Manufacturer
- Hospira, Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 66 Hudson St, N/A, New York, New York 10013
Distribution
- Quantity
- 3,546 vials
- Distribution pattern
- Nationwide in the USA, Netherlands and Libya
Timeline
- Recall initiated
- 2023-12-21
- FDA classified
- 2024-01-25
- Posted by FDA
- 2024-01-31
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0261-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.