Drug recall D-0247-2015
Product
HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC 63323-469-01
Reason for recall
Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result.
Lots and codes
Lot 6105149, Exp.05/14; 6105696, Exp. 07/14; 6105836, Exp. 08/14; Lot 6106516, Exp. 12/14; Lot 6106837, Exp. 02/15
Recall details
- Recalling firm
- Fresenius Kabi USA LLC, Melrose Park, IL
- Quantity
- 216,517 vials
- Distribution
- Nationwide and Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 14, 2014
- Terminated
- March 8, 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