Boehringer Ingelheim Roxane Inc recalls Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-
Recalled July 16, 2014 · FDA recall D-1427-2014 · Boehringer Ingelheim Roxane
Hazard
Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point · FDA Class II
Units
5364 bottles
Sold at
Nationwide
Description
Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point
Product
Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41.
Manufacturer(s)
Boehringer Ingelheim Roxane Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →