Class II
Terminated
Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41.
- Company
- Boehringer Ingelheim Roxane Inc
- Recall Initiated
- May 1, 2014
- Posted
- July 16, 2014
- Recall Number
- D-1427-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 5364 bottles
- Firm Location
- Columbus, OH, United States
Reason for Recall
Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point
Distribution
Nationwide
Lot / Code Info
Lot # 360122A, EXP Date: MAY 2015
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