Drug product
HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC 63323-469-01
D-0247-2015
Product summary
- Event
- Event 68019
- Status
- Terminated
- Classification
- Class III
- Quantity
- 216,517 vials
- Official record key
drug-enforcement:D-0247-2015
Official wording
Reason: Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result.
Code information: Lot 6105149, Exp.05/14; 6105696, Exp. 07/14; 6105836, Exp. 08/14; Lot 6106516, Exp. 12/14; Lot 6106837, Exp. 02/15
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
out-of-specification