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.
Reported: May 7, 2014 Initiated: March 20, 2014 #D-1299-2014
Product Description
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.
Reason for Recall
Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.
Details
- Recalling Firm
- Apotex Inc.
- Units Affected
- 11,422 bottles
- Distribution
- Nationwide and Puerto Rico.
- Location
- Toronto
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Apotex Inc.. Units affected: 11,422 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 7, 2014. Severity: Low. Recall number: D-1299-2014.
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