D-0819-2016 Class II Terminated
FDA drug recall D-0819-2016 was initiated by Fresenius Kabi USA, LLC on Apr 5, 2016 and is designated Class II. 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… The recall status is terminated (terminated Apr 11, 2017). Affected quantity: 94,560 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 20, 2016
- Initiation Date
- Apr 5, 2016
- Termination Date
- Apr 11, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 94,560 vials
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.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot #: 6010157, Exp. 01/2017
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0819-2016
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026