Home / Recalls / Validus Pharmaceuticals, Inc. / D-1170-2018

D-1170-2018 Class III Terminated

Recalled by Validus Pharmaceuticals, Inc. — Parsippany, NJ

Recall Details

Product Type: Drugs
Report Date: September 5, 2018
Initiation Date: June 15, 2018
Termination Date: January 22, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 7864 bottles

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

Reason for Recall

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

Distribution Pattern

U.S. nationwide

Code Information

RV1602RB, Exp 07/2019; RV1604RB, Exp 9/2019; RV1605RB, Exp 10/2019