Fresenius Kabi USA, LLC recalls Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use, Rx Only, 1 mL vial, APP ) 10 USP Units
Recalled July 24, 2013 · FDA recall D-804-2013 · Fresenius Kabi USA
Hazard
Subpotent Drug; 15-month stability test station · FDA Class II
Units
221,600 vials
Sold at
Nationwide and Puerto Rico
Description
Subpotent Drug; 15-month stability test station
Product
Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use, Rx Only, 1 mL vial, APP ) 10 USP Units/mL, 1 mL, APP Pharmaceuticals, LLC Schaumburg, IL, 60173, NDC 63323-012-01.
Manufacturer(s)
Fresenius Kabi USA, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →