Why it was recalled
Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.
Product description
Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with 1 single-dose 100ml vial of sterile water for Injection USP and one transfer device. Manufactured by: Genentech, Inc. 1 DNA Way, South San Francisco, CA 84080-4990. NDC: 50242-0085-27
Lot numbers, UPCs & expiration codes
Lot# 3128243, 3141239, EXP. 9/30/2018; 3166728, EXP. 2/28/2019.
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1175-2017
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Sep 5, 2017
- FDA report date
- Sep 27, 2017
- Quantity
- 16,882
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Genentech, Inc.
Original FDA data
Every field from FDA enforcement report D-1175-2017, exactly as published.
Show all FDA fields
- City
- South San Francisco
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 78088
- Address
- 1 Dna Way
- Code information
- Lot# 3128243, 3141239, EXP. 9/30/2018; 3166728, EXP. 2/28/2019.
- Postal code
- 94080-4990
- Report date
- Sep 27, 2017
- Product type
- Drugs
- Recall number
- D-1175-2017
- Classification
- Class I
- Recalling firm
- Genentech, Inc.
- Product quantity
- 16,882
- Termination date
- Jan 11, 2019
- Reason for recall
- Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with 1 single-dose 100ml vial of sterile water for Injection USP and one transfer device. Manufactured by: Genentech, Inc. 1 DNA Way, South San Francisco, CA 84080-4990. NDC: 50242-0085-27
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Sep 5, 2017
- Initial firm notification
- Letter
- Center classification date
- Dec 1, 2017