Class III
Terminated
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.
- Company
- Apotex Inc.
- Recall Initiated
- March 20, 2014
- Posted
- May 7, 2014
- Recall Number
- D-1299-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 11,422 bottles
- Firm Location
- Toronto, Canada
Reason for Recall
Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.
Distribution
Nationwide and Puerto Rico.
Lot / Code Info
Lot #: KD4855, Exp 06/14
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