Why it was recalled
Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition.
Product description
Soliris (eculizumab), 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
Lots: 10002-1, 00006-1, Exp 08/14; 10003A, Exp 11/14; 10004A, Exp 02/15; 10005A, 10005AR, 10007A, 10006A, Exp 07/15; and 10008A, Exp 08/15
Where it was sold
Nationwide and Puerto Rico
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-1512-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jun 2, 2014
- FDA report date
- Aug 13, 2014
- Quantity
- 96,506 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Alexion Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1512-2014, exactly as published.
Show all FDA fields
- City
- Cheshire
- State
- CT
- Status
- Terminated
- Country
- United States
- Event ID
- 68401
- Address
- 352 Knotter Dr
- Code information
- Lots: 10002-1, 00006-1, Exp 08/14; 10003A, Exp 11/14; 10004A, Exp 02/15; 10005A, 10005AR, 10007A, 10006A, Exp 07/15; and 10008A, Exp 08/15
- Postal code
- 06410-1138
- Report date
- Aug 13, 2014
- Product type
- Drugs
- Recall number
- D-1512-2014
- Classification
- Class I
- Recalling firm
- Alexion Pharmaceuticals, Inc.
- Product quantity
- 96,506 vials
- Termination date
- May 29, 2015
- Reason for recall
- Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Soliris (eculizumab), 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 and Puerto Rico
- Recall initiation date
- Jun 2, 2014
- Initial firm notification
- Press Release
- Center classification date
- Aug 5, 2014