Recall: D-1386-2019

Class III - Minor Violations

Class IIIClassification

2019-05-22Initiated

TerminatedStatus

Fresenius Kabi USA, LLCFirm

Product

Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, NDC 63323-374-20

Reason

Failed Impurities/Degradation Specifications.

Distribution

Nationwide within the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.