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
Reported: April 20, 2016 Initiated: April 5, 2016 #D-0819-2016
Product Description
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
Reason for Recall
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.
Details
- Recalling Firm
- Fresenius Kabi USA, LLC
- Units Affected
- 94,560 vials
- Distribution
- Nationwide and Puerto Rico
- Location
- Lake Zurich, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Fresenius Kabi USA, LLC. Units affected: 94,560 vials.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 20, 2016. Severity: Moderate. Recall number: D-0819-2016.
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