FDAFDA · Food and drugs·Recall number D-0296-2015
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
Published December 17, 2014 · Recall initiated: September 27, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ONDANSETRON
- Manufacturer
- Fresenius Kabi USA, LLC
- Distributor
- U.S. Nationwide Including Puerto Rico
- UPC
- 0363323374204
- Lot
- Lot 6003930, exp. date 04/2014
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.