Reported May 7, 2014 · Terminated
Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L…
Apotex Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Apotex Inc. · 150 Signet Drive · Toronto · N/A
Is this the product you have?
- 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.
- Lot codes and dates
Lot #: KD4855Exp 06/14
- Amount recalled
- 11,422 bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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