Recalls / Class III
Class IIID-1299-2014
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.
- Affected lot / code info
- Lot #: KD4855, Exp 06/14
Why it was recalled
Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.
Recalling firm
- Firm
- Apotex Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 150 Signet Drive, Toronto, N/A, Canada
Distribution
- Quantity
- 11,422 bottles
- Distribution pattern
- Nationwide and Puerto Rico.
Timeline
- Recall initiated
- 2014-03-20
- FDA classified
- 2014-05-01
- Posted by FDA
- 2014-05-07
- Terminated
- 2014-12-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1299-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.