Drug recall D-0296-2015
Product
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.
Lots and codes
Lot 6003930, exp. date 04/2014
Recall details
- Recalling firm
- Fresenius Kabi USA, LLC, Lake Zurich, IL
- Quantity
- 184,550 Vials
- Distribution
- U.S. Nationwide Including Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- September 27, 2012
- Terminated
- December 12, 2014
Related products
- Ondansetron – drug information
- NDC 63323-373 Ondansetron · Ondansetron Hydrochloride 2 mg/mL · Fresenius Kabi USA, LLC
- NDC 63323-374 Ondansetron · Ondansetron Hydrochloride 2 mg/mL · Fresenius Kabi USA, LLC