FDAFDA · Food and drugs·Recall number D-0819-2016
Cisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), For intravenous injection, 10 mL Multiple Dose Vial, Rx only, Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-417-10
Published April 20, 2016 · Recall initiated: April 5, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of Preservative free on the individual carton label. The vial label and outer carton label contain the correct statement of 0.9% benzyl alcohol added as a preservative.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CISATRACURIUM
- Manufacturer
- Fresenius Kabi USA, LLC
- Distributor
- Nationwide and Puerto Rico
- UPC
- 0363323418014
- Lot
- Lot #: 6010157, Exp. 01/2017
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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