Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-469-01.
Recall Number: D-0818-2016
Firm: Fresenius Kabi USA, LLC
Classification: Class III
Status: Terminated
Report Date: 20160420
Initiation Date: 20160407
Termination Date: 20161107
Reason for Recall
Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.
Product Description
Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-469-01.