Drug recall D-1427-2014

Class II Terminated reported Jul 16, 2014

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

Lots and codes

Lot # 360122A, EXP Date: MAY 2015

Recall details

Recalling firm
Boehringer Ingelheim Roxane Inc, Columbus, OH
Quantity
5364 bottles
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
May 1, 2014
Terminated
April 1, 2015

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