D-1299-2014 Class III Terminated
FDA drug recall D-1299-2014 was initiated by Apotex Inc. on Mar 20, 2014 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point. The recall status is terminated (terminated Dec 23, 2014). Affected quantity: 11,422 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- May 7, 2014
- Initiation Date
- Mar 20, 2014
- Termination Date
- Dec 23, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,422 bottles
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.
Distribution pattern
Nationwide and Puerto Rico.
Code information
Lot #: KD4855, Exp 06/14
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1299-2014
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026