D-0818-2016 Class III Terminated
FDA drug recall D-0818-2016 was initiated by Fresenius Kabi USA, LLC on Apr 7, 2016 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result. The recall status is terminated (terminated Nov 7, 2016). Affected quantity: 48,210 units.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 20, 2016
- Initiation Date
- Apr 7, 2016
- Termination Date
- Nov 7, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 48,210 units
Product Description
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.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot #: 6111080, Exp. 01/2017
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0818-2016
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026