Drug product
Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41.
D-1427-2014
Product summary
- Event
- Event 68389
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5364 bottles
- Official record key
drug-enforcement:D-1427-2014
Official wording
Reason: Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point
Code information: Lot # 360122A, EXP Date: MAY 2015
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification