Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop vial, Rx Only, Distr...

FDA Recall #D-0261-2024 — Class I — December 21, 2023

Recall #D-0261-2024 Date: December 21, 2023 Classification: Class I Status: Ongoing

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

Reason for Recall

Presence of particulate matter: glass

Recalling Firm

PFIZER — New York, NY

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

3,546 vials

Distribution

Nationwide in the USA, Netherlands and Libya

Code Information

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated