Drug recall: Bleomycin injection vials recalled due to glass contamination
Pfizer is recalling 3,546 vials of Bleomycin for Injection due to the presence of glass particulate matter. The affected lot was distributed nationwide in the USA, Netherlands, and Libya.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall is classified as FDA Class I, which mandates a minimum severity of Severe (4) per the rubric. No deaths or serious injuries are reported in the source, so it does not meet the threshold for Critical (5).
Plain-English summary
Pfizer is recalling 3,546 vials of Bleomycin for Injection, USP (15 units per vial) because they contain glass particulate matter. The recalled lot (BL12206A, expiration date 06/30/2024) was distributed nationwide in the USA, the Netherlands, and Libya.
Bleomycin is administered by injection (intramuscular, intrapleural, intravenous, or subcutaneous routes). The FDA has classified this as a Class I recall, indicating a serious hazard to health due to the glass contamination.
Healthcare providers who have dispensed vials from lot BL12206A with an expiration date of 06/30/2024 should immediately stop using them. Patients who have received injections from this recalled lot should contact their healthcare provider regarding this recall.
The recalled product
- Product
- BLEOMYCIN (BLEOMYCIN)
- Brand
- BLEOMYCIN
- Manufacturer
- PFIZER
- Category
- Drug — Injectable
- Hazard
- glass-contamination
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 (2)
- Lot #: BL12206A
- Exp date 06/30/2024
Distribution
Distributed nationwide across the United States.
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