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Recall Observatory FDA recall evidence

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

March 20, 2014

Class III

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

    reason.potency_specification_failure · v1.0.0

    Out of Specification