6/21/2024

Alteplase Injection (Cathflo Activase)

Products Affected - Description

- Cathflo Activase intravenous lyophilized powder for injection, Genentech, 2 mg, vial, 1 count, NDC 50242-0041-64
- Cathflo Activase intravenous lyophilized powder for injection, Genentech, 2 mg, vial, 10 count, NDC 50242-0041-10

Reason for the Shortage

- On May 28, 2024, Genentech issued a voluntary recall of two batches (batches 3618873 and 3618858) of Cathflo Activase due to defective stoppers. Defective stoppers may not seal properly resulting in potential container closure integrity and sterility concerns. Additional information can be found at https://www.gene.com/download/pdf/Cathflo-Activase_DHCP_Important_Drug_Warning_2024-05-28.pdf.

Available Products

- There is insufficient supply for usual ordering

Estimated Resupply Dates

- Genentech has Cathflo Activase 2 mg vials in single count packages on back order and the company estimates a release date in early-July 2024. The 2 mg vials in 10 count packages are available in limited supply. Additional supplies of the 10 count packages are also estimated to be released in early-July 2024.

Updated

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