Why it was recalled
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Product description
Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
Lot numbers, UPCs & expiration codes
Lot #: 3618858, 3618873, Exp. Date 01/31/2026
Where it was sold
Nationwide within the United States
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-0509-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 20, 2024
- FDA report date
- Jun 5, 2024
- Quantity
- Lot:3618858 = 105,759; Lot:3618873 =90,359
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Genentech, Inc.
Original FDA data
Every field from FDA enforcement report D-0509-2024, exactly as published.
Show all FDA fields
- City
- South San Francisco
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 94653
- Address
- 1 Dna Way Bldg 5
- Code information
- Lot #: 3618858, 3618873, Exp. Date 01/31/2026
- Postal code
- 94080-4918
- Report date
- Jun 5, 2024
- Product type
- Drugs
- Recall number
- D-0509-2024
- Classification
- Class II
- Recalling firm
- Genentech, Inc.
- Product quantity
- Lot:3618858 = 105,759; Lot:3618873 =90,359
- Termination date
- Aug 11, 2025
- Reason for recall
- Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- May 20, 2024
- Initial firm notification
- Letter
- Center classification date
- May 24, 2024