Why it was recalled
Presence of Particulate Matter: Failed the appearance test for the presence of visible particles.
Product description
Soliris (eculizumab) Concentrated Solution for Intravenous Infusion Only, 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufactured by: Alexion Pharmaceuticals, Inc., Cheshire, CT 06410, NDC 25682-001-01, UPC 3 25682-001-01 6.
Lot numbers, UPCs & expiration codes
Lot #: 10001-1, Exp 07/14; 10010A, Exp 10/15
Where it was sold
Nationwide, Puerto Rico, Jamaica, and Grenada.
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-1049-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Nov 4, 2013
- FDA report date
- Feb 5, 2014
- Quantity
- 21,661 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Alexion Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1049-2014, exactly as published.
Show all FDA fields
- City
- Cheshire
- State
- CT
- Status
- Terminated
- Country
- United States
- Event ID
- 66771
- Address
- 352 Knotter Dr
- Code information
- Lot #: 10001-1, Exp 07/14; 10010A, Exp 10/15
- Postal code
- 06410-1138
- Report date
- Feb 5, 2014
- Product type
- Drugs
- Recall number
- D-1049-2014
- Classification
- Class I
- Recalling firm
- Alexion Pharmaceuticals, Inc.
- Product quantity
- 21,661 vials
- Termination date
- Mar 2, 2015
- Reason for recall
- Presence of Particulate Matter: Failed the appearance test for the presence of visible particles.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Soliris (eculizumab) Concentrated Solution for Intravenous Infusion Only, 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufactured by: Alexion Pharmaceuticals, Inc., Cheshire, CT 06410, NDC 25682-001-01, UPC 3 25682-001-01 6.
- Distribution pattern
- Nationwide, Puerto Rico, Jamaica, and Grenada.
- Recall initiation date
- Nov 4, 2013
- Initial firm notification
- Center classification date
- Jan 30, 2014