ONDANSETRON INJECTION, USP, 4 mg/ 2 mL (2 mg/mL), For IM or IV Use, Single Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumburg, IL 60173. NDC: 63323-373-02
Reported: December 17, 2014 Initiated: September 27, 2012 #D-0296-2015
Product Description
ONDANSETRON INJECTION, USP, 4 mg/ 2 mL (2 mg/mL), For IM or IV Use, Single Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumburg, IL 60173. NDC: 63323-373-02
Reason for Recall
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
Details
- Recalling Firm
- Fresenius Kabi USA, LLC
- Units Affected
- 184,550 Vials
- Distribution
- U.S. Nationwide Including Puerto Rico
- Location
- Lake Zurich, IL
Frequently Asked Questions
What product was recalled? ▼
ONDANSETRON INJECTION, USP, 4 mg/ 2 mL (2 mg/mL), For IM or IV Use, Single Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumburg, IL 60173. NDC: 63323-373-02. Recalled by Fresenius Kabi USA, LLC. Units affected: 184,550 Vials.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 17, 2014. Severity: Moderate. Recall number: D-0296-2015.
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