drugs Class III Updated 2014-05-07

Apotex Inc. recalls Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, M

Recalled 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.

Hazard / Issue

Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #: KD4855, Exp 06/14
View official government recall

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