Drug recall D-0818-2016
Product
Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-469-01.
Reason for recall
Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.
Lots and codes
Lot #: 6111080, Exp. 01/2017
Recall details
- Recalling firm
- Fresenius Kabi USA, LLC, Lake Zurich, IL
- Quantity
- 48,210 units
- Distribution
- Nationwide and Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 7, 2016
- Terminated
- November 7, 2016
Related products
- Haloperidol Decanoate – drug information
- NDC 63323-471 Haloperidol Decanoate · Haloperidol Decanoate 100 mg/mL · Fresenius Kabi USA, LLC
- NDC 63323-469 Haloperidol Decanoate · Haloperidol Decanoate 50 mg/mL · Fresenius Kabi USA, LLC