Activase recall: Sterility Concern
Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with 1 single-dose 100ml vial of sterile water for Injection USP and one…
Why was Activase recalled?
Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.
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?
Lot# 3128243, 3141239, EXP. 9/30/2018; 3166728, EXP. 2/28/2019.
- Product
- Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with 1 single-dose 100ml vial of sterile water for Injection USP and one…
- Recalling firm
- Genentech, Inc.
- Quantity
- 16,882
- Distribution
- Nationwide in the USA
- Recall date
- September 27, 2017
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (drug)