Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA, NDC 63304-241-59

Recall Number: D-1170-2018

Firm: Validus Pharmaceuticals, Inc.

Classification: Class III

Status: Terminated

Report Date: 20180905

Initiation Date: 20180615

Termination Date: 20210122

Reason for Recall

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

Product Description

Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA, NDC 63304-241-59