Pfizer’s Hospira, Inc. Initiates Voluntary Recall of Bleomycin for Injection Due to Glass Particulate Contamination

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Pfizer's Hospira, Inc. Initiates Voluntary Recall of Bleomycin for Injection Due to Glass Particulate Contamination — Bleomycin USP 15 units Single Dose

Pfizer’s Hospira, Inc., a leading pharmaceutical company, has issued a voluntary recall of one lot of Bleomycin for Injection, USP 15 units Single Dose ONCO-TAIN™ Glass Fliptop Vial, with lot number BL12206A. The decision to recall the product was made following a confirmed customer report of the presence of glass particulate within a single vial.

Patients who receive injectable products containing glass particulate matter face potential adverse events, including injection site reactions, localized vein inflammation or phlebitis, thrombus, embolus, and/or end-organ granuloma, or life-threatening blood clot events. However, the risk can be mitigated through detection, as the product label instructs healthcare professionals to visually inspect for particulate matter and discoloration before administration.

As of now, Pfizer has not received any reports of adverse events related to this recall. Bleomycin for Injection, USP, is a cytotoxic glycopeptide antibiotic mixture useful in the palliative treatment of neoplasms, either as a single agent or in combination with other approved chemotherapeutic agents.

Patients without contraindicated devices need not take any action. However, wholesalers, hospitals, institutions, and doctors with the affected lot in their inventory are instructed to discontinue use, stop distribution, and quarantine the product immediately.

Pfizer has prioritized patient safety and product quality throughout the manufacturing and supply chain process. Direct consignees have been notified by letter to facilitate the return of the recalled product. Any further distribution of the recalled lot should be communicated to relevant accounts and locations.

For additional assistance, a dedicated hotline has been established by Sedgwick Inc. at 1-800-805-3093, available from 8 a.m. to 5 p.m. ET, Monday through Friday.

Healthcare professionals with questions about the recall can contact Pfizer through the provided contact information:

Pfizer Medical Information: 1-800-438-1985, option 3 (9 a.m. to 5 p.m. ET, Monday through Friday) or www.pfizermedinfo.com 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.

Patients and healthcare professionals are encouraged to report any adverse reactions or quality problems associated with the use of this product to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

This voluntary recall is being conducted in coordination with the U.S. Food and Drug Administration (FDA). For further information, consumers can contact Sedgwick Inc. at 1-800-805-3093, and media inquiries can be directed to Pfizer’s Media Relations at 1-212-733-7410 or steve.danehy@pfizer.com.