Recalls / Class II
Class IID-0819-2016
Product
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
- Brand name
- Cisatracurium
- Generic name
- Cisatracurium Besylate
- Active ingredient
- Cisatracurium Besylate
- Route
- Intravenous
- NDCs
- 63323-416, 63323-417, 63323-418
- FDA application
- ANDA203182
- Affected lot / code info
- Lot #: 6010157, Exp. 01/2017
Why it was 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.
Recalling firm
- Firm
- Fresenius Kabi USA, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Corporate Dr, N/A, Lake Zurich, Illinois 60047-8930
Distribution
- Quantity
- 94,560 vials
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2016-04-05
- FDA classified
- 2016-04-12
- Posted by FDA
- 2016-04-20
- Terminated
- 2017-04-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0819-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.