Safety Report: Hospira, Inc. Bleomycin for Injection, USP 15 Units Single Dose ONCO-TAIN™ Glass Fliptop Vial - recalled due to Presence of Glass Particulate Matter, USA

United States

Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Bleomycin for Injection, USP 15 units Single Dose ONCO-TAIN™ Glass Fliptop Vial, to the user level. The recall was initiated due to a confirmed customer report for the presence of glass particulate within a single vial. To date, Pfizer has not received reports of any adverse events related to this recall.

Should a patient receive an 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.

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.

- Product: Bleomycin for Injection, USP, 15 Units Single-Dose ONCO-TAIN™ Glass Fliptop Vial, NDC: 61703-332-18, Lot Number: BL12206A, Expiration Date: 30JUN2024, Presentation: 15units/ vial lyophilized, Configuration/Count: 1 vial per carton, 112 vials per case.

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.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Hospira, Inc.
Brand name: No Brand
Product recalled: Bleomycin for Injection, USP 15 Units Single Dose ONCO-TAIN™ Glass Fliptop Vial
Reason of the recall: Presence of Glass Particulate Matter
FDA Recall date: December 22, 2023

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hospira-inc-issues-voluntary-nationwide-recall-one-lot-bleomycin-injection-usp-15-units-single-dose