FDAFDA · Food and drugs·Recall number D-1299-2014
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.
Published May 7, 2014 · Recall initiated: March 20, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Apotex Inc.
- Distributor
- Nationwide and Puerto Rico.
- Lot
- Lot #: KD4855, Exp 06/14
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- Canada
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