Recall: D-1427-2014

Class II - Potentially Harmful

Class IIClassification

2014-05-01Initiated

TerminatedStatus

Boehringer Ingelheim Roxane InFirm

Product

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

Reason

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

Distribution

Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.