Hospira, Inc. Issues A Voluntary Nationwide Recall For One Lot of Bleomycin for Injection, USP 15 Units Single Dose ONCO-TAIN™ Glass Fliptop Vial Due To The Potential For Presence of Glass Particulate Matter
FOR IMMEDIATE RELEASE - December 21, 2023 - NEW YORK, NY.
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.
The NDC, Lot Number, Expiration Date, and Configuration details for Bleomycin for injection, USP are indicated below. The product was distributed nationwide to wholesalers/hospitals/institutions in the United States from January 11, 2023 through May 11, 2023.
|Bleomycin for Injection, USP, 15 Units Single-Dose ONCO-TAIN™ Glass Fliptop Vial
|15 units/ vial lyophilized
|1 vial per carton, 112 vials per case
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. For additional assistance, call Sedgwick Inc. at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.
Healthcare Professionals with questions regarding this recall can contact Pfizer using the below information.
|Area of Support
|Pfizer Medical Information
|1-800-438-1985, option 3 (9am to 5pm ET Monday through Friday) www.pfizermedinfo.com
|For medical questions regarding the product
|1-800-438-1985, option 1 (24 hours a day; 7 days a week)
|To report adverse events and product complaints
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.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete the form and return it to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
This recall is being executed with the knowledge of the U.S. Food and Drug Administration.
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Bleomycin for Injection, USP Single-Dose Vial, 15 units per vial For Intravenous, Intramuscular, Subcutaneous and Intrapleural Use
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