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

Recall Number: D-1171-2018

Firm: Validus Pharmaceuticals, Inc.

Classification: Class III

Status: Terminated

Report Date: 20180905

Initiation Date: 20180615

Termination Date: 20210122

Subpotency: lower than expected potency result was obtained at the 18 month stability time point.

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