Class I Recall for Cancer Drug

A Class I recall has been issued for 3546 vials of bleomycin for injection distributed by Hospira Inc., a Pfizer company, according to the January 31, 2024, US Food and Drug Administration (FDA) Enforcement Report. The recall was initiated after a customer found glass particulate in a vial. The FDA’s most serious recall category, a Class I designation warns use of the affected product could cause serious adverse health consequences or death.

“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,” Hospira stated in a December 21, 2023, announcement.

The recall affects bleomycin for injection, 15 units per single-dose Onco-Tain glass fliptop vial (NDC 61703-332-18), from lot BL12206A (Exp. 6/30/24). The vials were distributed by Hospira, Lake Forest, Illinois, throughout the United States as well as in the Netherlands and Libya. Pfizer Inc. voluntarily initiated the recall December 21, 2023. On January 25, 2024, the FDA designated it Class I.

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