FDA-Drug2014-05-07Class III
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.
Apotex Inc.
Hazard
Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.
Sold states
Nationwide and Puerto Rico.
Affected count
11,422 bottles
Manufactured in
150 Signet Drive, Toronto, Canada
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1299-2014Don't want to check this manually?
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