FDA warns – 1 lot of Bleomycin for Injection, USP 15 Units Single Dose ONCO-TAIN™ Glass Fliptop Vial recalled due to potential trace of glass particulate matter

According to the FDA, Pfizer company Hospira, Inc. has voluntarily recalled a single lot (lot BL12206A) of its Bleomycin for Injection, USP 15 Units Single Dose ONCO-TAIN™ Glass Fliptop Vial because the product may contain glass particulate matter.

While Pfizer has not been made aware of any adverse events associated with the issue, officials initiated the recall to the user-level on December 21, 2023, after verifying a customer report which indicated glass particulate was found in a single vial.

Containing a variety of “cytotoxic glycopeptide antibiotics isolated from a strain of Streptomyces verticillus,” officials say Bleomycin for Injection, USP is indicated as a palliative treatment. It may be used to manage neoplasms on its own, or can also be effectively combined with other authorized chemotherapeutic agents.

Injectable products that contain glass particulate matter may cause patients to suffer a range of adverse events that include “injection site reaction, localized vein inflammation or phlebitis, thrombus, embolus and/or end-organ granuloma,” as well as blood clot events that could be life-threatening. As indicated by a statement printed on the product label, healthcare professionals may help reduce risks to patients by visually inspecting the product for particulate matter and any discoloration before administering it.

After identifying the problem, Pfizer alerted all of its direct partners by letter and established a return program for all recalled product.

Any entity, including “wholesalers, hospitals, institutions, and doctors” that carries the affected lot in their inventory is instructed to cease all use and distribution of the products. The items should be immediately quarantined. Any sub-distributors and any additional locations may have received recalled product should also be notified, as well as any healthcare professionals associated with hospitals and relevant institutions.

Further questions or concerns may be directed to Sedgwick Inc. at 1-800-805-3093. Representatives can be reached Monday through Friday, from 8:00 a.m. to 5:00 p.m. Eastern time.

Healthcare professionals with questions about the recall may contact Pfizer using the contact information provided in the FDA announcement.

As the FDA continues to monitor this recall, the agency asks that adverse reactions or quality issues be reported to its MedWatch program.


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