Reported Jul 16, 2014 · Terminated
Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC…
Boehringer Ingelheim Roxane Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boehringer Ingelheim Roxane Inc · 1809 Wilson Rd · Columbus, OH · 43228-9579
Is this the product you have?
- Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41.
- Lot codes and dates
- Lot # 360122A
- EXP DateMAY 2015
- Amount recalled
- 5364 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point
This product could cause temporary or reversible health problems — stop using it.
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