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.

FDA recall notice · announced May 7, 2014 · Apotex

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Reason for recall

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

Notes

Distribution: Nationwide and Puerto Rico.
Lot/code information: Lot #: KD4855, Exp 06/14
Quantity: 11,422 bottles
Status: Terminated
Products in this recall event:
- 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. (D-1299-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.