Medicine recalls
|
| |
| The United States: 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 |
| |
The US Food and Drug Administration (FDA) announces that 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. For patients where they, or anyone in close physical contact, do not have a contraindicated device, no action is needed.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hospira-inc-issues-voluntary-nationwide-recall-one-lot-bleomycin-injection-usp-15-units-single-dose
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by Health Canada, and was posted on the Drug Office website on 22 Dec 2023.
Ends/ Saturday, Dec 23, 2023
Issued at HKT 12:00
|
| |
|
