FDA Recall D-0261-2024

PFIZER · New York, NY

Class I — life-threatening Ongoing 875 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

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

Lot / code: Lot #: BL12206A, Exp date 06/30/2024

Quantity: 3,546 vials

Reason for recall

Presence of particulate matter: glass

Recall record

Recall number: D-0261-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Nationwide in the USA, Netherlands and Libya
Recall initiated: 2023-12-21
Classified by FDA Center: 2024-01-25
FDA published: 2024-01-31
Recalling firm: PFIZER
Firm location: New York, NY

Drug identification

Brand name(s): BLEOMYCIN
Generic name(s): BLEOMYCIN
Manufacturer(s): Hospira, Inc.
NDC(s): 61703-323, 61703-332
Route(s): INTRAMUSCULAR, INTRAPLEURAL, INTRAVENOUS, SUBCUTANEOUS

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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