Apotex Inc. recalls Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9
Recalled May 7, 2014 · FDA recall D-1299-2014 · Apotex
Hazard
Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point. · FDA Class III
Units
11,422 bottles
Sold at
Nationwide and Puerto Rico.
Description
Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.
Product
Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-0380-1.
Manufacturer(s)
Apotex Inc.
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →