FDAFDA · Food and drugs·Recall number D-1427-2014
Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41.
Published July 16, 2014 · Recall initiated: May 1, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point
What to do
Voluntary: Firm initiated
Recall details
- Brand
- CALCITRIOL
- Manufacturer
- Boehringer Ingelheim Roxane Inc
- Distributor
- Nationwide
- Lot
- Lot # 360122A, EXP Date: MAY 2015
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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