Recall Enforment Report D-0261-2024

Drug Recall Enforcement Report Class I voluntary initiated by PFIZER, originally initiated on 12-21-2023 for the 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 The product was recalled due to presence of particulate matter: glass. The product was distributed nationwide and the recall is currently ongoing.

Field Name	Field Value
Event ID	93693 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0261-2024 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA, Netherlands and Libya What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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 What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	3,546 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	01-31-2024
Recall Initiation Date	12-21-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Press Release Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	PFIZER
Code Info	Lot #: BL12206A, Exp date 06/30/2024 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	61703-323-22; 61703-332-18
Status	Ongoing

Recalled Products