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Recall Observatory FDA recall evidence

Drug 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

D-0261-2024

December 21, 2023

Class I

Product summary

Firm
PFIZER
Event
Event 93693
Status
Ongoing
Classification
Class I
Quantity
3,546 vials
Official record key
drug-enforcement:D-0261-2024

Official wording

Reason: Presence of particulate matter: glass

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

Distribution pattern: Nationwide in the USA, Netherlands and Libya

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    particulate matter