FDAClass IIJune 2, 2021

cathflo activase recall: CGMP Deviations

cathflo activase (ALTEPLASE) 2 mg Rx Only NDC 50242-041-64 Genentech

Why was cathflo activase recalled?

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

3410425

Product
cathflo activase (ALTEPLASE) 2 mg Rx Only NDC 50242-041-64 Genentech
Recalling firm
Cardinal Health Inc.
Quantity
1473 vials
Distribution
FL, GA, SC
Recall date
June 2, 2021
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls