← FDA ENFORCEMENT
D-0261-2024Class I
PFIZER
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
PFIZER
Product type
Drug
Status
Ongoing
Report date
2024-01-31
Distribution
Nationwide in the USA, Netherlands and Libya
Firm state
NY
Product quantity
3,546 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental MonitoringReason for recall
Presence of particulate matter: glass
Product description
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
Code / lot info
Lot #: BL12206A, Exp date 06/30/2024
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →