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  5. FDA Recall: Haloperidol Decanoate

FDA Recall Haloperidol Decanoate

View Recall Number, Date, Reasons, Quantity

FDA Recall Enforcement Reports

The last Recall Enforcement Report for Haloperidol Decanoate with NDC 63323-471 was initiated on 04-07-2016 as a Class III recall due to failed impurities/degradation specifications: firm is recalling product due to an impurity out-of-specification result. The latest recall number for this product is D-0818-2016 and the recall is currently terminated as of 11-07-2016 .

Recall Number Initiation Date Report Date Recall Classification Product Quantity Product Description Status
D-0818-201604-07-201604-20-2016Class III48,210 unitsHaloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-469-01.Terminated
D-0247-201504-14-201411-19-2014Class III216,517 vialsHALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC 63323-469-01Terminated

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.