drugs Class II Updated 2014-07-16

Boehringer Ingelheim Roxane Inc recalls Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Rox

Recalled Product

Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41.

Hazard / Issue

Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot # 360122A, EXP Date: MAY 2015
View official government recall

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