Product: Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL, 15 mL bottle, Rx only, Distributed by: Validus Pharmaceuticals, LLC Parsippany, NJ 07054 USA, NDC 30698-911-15
Reason for recall: Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
Recall initiated: 20180615
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated