Hospira, Inc., a Pfizer company, Recalls One Lot of Bleomycin for Injection


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Bleomycin Vial


Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Bleomycin for Injection, USP 15 units Single Dose ONCO-TAIN™ Glass Fliptop Vial, lot BL12206A, to the user level. The recall was initiated due to a confirmed customer report for the presence of glass particulate within a single vial.

Should a patient receive injectable product containing glass particulate matter as a result of this issue, the patient may experience adverse events including injection site reaction, localized vein inflammation or phlebitis, thrombus, embolus and/or end-organ granuloma or life-threatening blood clot events. The risk is reduced by the possibility of detection, as the label contains a statement directing the healthcare professional to visually inspect the product for particulate matter and discoloration prior to administration.

To date, Pfizer has not received reports of any adverse events related to this recall.

Bleomycin for Injection, USP is a mixture of cytotoxic glycopeptide antibiotics isolated from a strain of Streptomyces verticillus. It should be considered a palliative treatment useful in the management of the neoplasms either as a single agent or in proven combinations with other approved chemotherapeutic agents.

For patients where they, or anyone in close physical contact, do not have a contraindicated device, no action is needed.

Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Pfizer has notified direct consignees by letter to arrange for return of any recalled product.

Wholesalers, hospitals, institutions, and doctors with an existing inventory of the lot, which is being recalled, should discontinue use, stop distribution, and quarantine the product immediately. If you have further distributed the recalled product, please notify your accounts and/or any additional locations which may have received the recalled product. Hospitals/Institutions should inform Healthcare Professionals in your organization of this recall. 

Source: FDA

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Contact Center

Contact Information

Area of Support

Pfizer Medical Information 1-800-438-1985, option 3
(9am to 5pm ET Monday
through Friday)
www.pfizermedinfo.comExternal Link Disclaimer
For medical questions
regarding the product
Pfizer Safety 1-800-438-1985, option 1
(24 hours a day;
7 days a week)
To report adverse events
and product complaints

Recalled Product Details

Product

NDC

Lot Number

Expiration Date

Presentation

Configuration/Count

Bleomycin for Injection, USP,
15 Units
Single-Dose
ONCO-TAIN™
Glass Fliptop Vial
61703-332-18 BL12206A 30JUN2024 15units/ vial
lyophilized
1 vial per carton,
112 vials per case

Report a Problem With This Product

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

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