Drug product
Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-469-01.
D-0818-2016
Product summary
- Event
- Event 73652
- Status
- Terminated
- Classification
- Class III
- Quantity
- 48,210 units
- Official record key
drug-enforcement:D-0818-2016
Official wording
Reason: Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.
Code information: Lot #: 6111080, Exp. 01/2017
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
out-of-specification