Product: Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41.
Reason for recall: Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point
Recall initiated: 20140501
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated