Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop vial, Rx Only, Distributed by: Hospira, Inc
Summary
The FDA issued a Class I for Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop via by PFIZER. Reason: Presence of particulate matter: glass.
Details
Source
Drug Recall
External ID
D-0261-2024
Action Date
2024-01-31
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot #: BL12206A, Exp date 06/30/2024
Quantity Affected: 3,546 vials
Reason for Recall
Presence of particulate matter: glass
Distribution
Nationwide in the USA, Netherlands and Libya
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-21
Company
New York, NY
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 60 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
PFIZER has 28 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (PFIZER) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does PFIZER have FDA actions?
PFIZER has 28 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0261-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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