Drug 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.
D-1299-2014
Product summary
- Firm
- Apotex Inc.
- Event
- Event 67985
- Status
- Terminated
- Classification
- Class III
- Quantity
- 11,422 bottles
- Official record key
drug-enforcement:D-1299-2014
Official wording
Reason: Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.
Code information: Lot #: KD4855, Exp 06/14
Distribution pattern: Nationwide and Puerto Rico.
Derived failure modes
-
Potency or specification failure
Out of Specification