SOUTH SAN FRANCISCO, CA — Three lots of alteplase (Activase, Genentech/Roche) 100 mg are being recalled because vials of water for injection with which it was packaged may be “cracked or chipped at the neck” and leaking, their contents no longer sterile, the company and the US Food and Drug Administration have announced[1,2].
The vials of water were manufactured by Hospira/Pfizer, says Genentech, which “has not received reports of adverse events associated with use of impacted sterile water for injection.”
The recall applies to lots 3128243, 3141239, and 3166728 shipped to US hospitals from January 6, 2017 to May 19, 2017.
Alteplase is indicated in the US for acute ischemic stroke given within 3 hours of onset, “acute massive pulmonary embolism,” and acute MI.
“Healthcare providers that have lots of Activase that have been recalled should stop using the product and should return the affected lots to Genentech,” says the company. It has alerted “distributers and customers” and is “arranging for the return of all recalled products.”
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