Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41.
Recall Number: D-1427-2014
Firm: Boehringer Ingelheim Roxane Inc
Classification: Class II
Status: Terminated
Report Date: 20140716
Initiation Date: 20140501
Termination Date: 20150401
Reason for Recall
Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point
Product Description
Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41.