FDA recall D-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.

Reason for recall

Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.

Distribution

Nationwide and Puerto Rico.

Key facts

Status

Terminated

Initiation date

2014-03-20

Report date

2014-05-07

Termination date

2014-12-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Toronto, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1299-2014