D-0247-2015 Class III Terminated
FDA drug recall D-0247-2015 was initiated by Fresenius Kabi USA LLC on Apr 14, 2014 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result. The recall status is terminated (terminated Mar 8, 2016). Affected quantity: 216,517 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 19, 2014
- Initiation Date
- Apr 14, 2014
- Termination Date
- Mar 8, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 216,517 vials
Product Description
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.
Distribution Pattern
Nationwide and Puerto Rico
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0247-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026