Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.
Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-469-01.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
Reason Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Reason Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Reason Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Reason Lack of Assurance of Sterility: Media fill with bacterial contamination
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