Soliris recall: Particulate Matter
Soliris (eculizumab) Concentrated Solution for Intravenous Infusion Only, 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufactured by…
Why was Soliris recalled?
Presence of Particulate Matter: Failed the appearance test for the presence of visible particles.
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 #: 10001-1, Exp 07/14; 10010A, Exp 10/15
- Product
- Soliris (eculizumab) Concentrated Solution for Intravenous Infusion Only, 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufactured by…
- Recalling firm
- Alexion Pharmaceuticals, Inc.
- Quantity
- 21,661 vials
- Distribution
- Nationwide, Puerto Rico, Jamaica, and Grenada.
- Recall date
- February 5, 2014
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (drug)