Bleomycin Injection, Powder, Lyophilized, For Solution
FDA Recall NDC 61703-332
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Bleomycin (NDC 61703-332). A significant event, classified as Class I, was initiated on Dec 21, 2023 by Hospira, Inc.. The reported reason for this action was: "Presence of particulate matter: glass"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class I Ongoing
Presence of particulate matter: glass
Dec 21, 2023
Jan 31, 2024
3,546 vials
Recall Profile & Regulatory Data
Event ID
93693
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
PFIZER
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA, Netherlands and Libya
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
Batch or Lot Expiration Information
Lot# : BL12206A, Exp date 06/30/2024
Affected Packages Involved in this Recall
61703-323-22Product
61703-332-18Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
