D-0296-2015 Class II Terminated
FDA drug recall D-0296-2015 was initiated by Fresenius Kabi USA, LLC on Sep 27, 2012 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles. The recall status is terminated (terminated Dec 12, 2014). Affected quantity: 184,550 Vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 17, 2014
- Initiation Date
- Sep 27, 2012
- Termination Date
- Dec 12, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 184,550 Vials
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.
Distribution Pattern
U.S. Nationwide Including Puerto Rico
Code Information
Lot 6003930, exp. date 04/2014
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0296-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026