Home / Recalls / Validus Pharmaceuticals, Inc. / D-1171-2018

D-1171-2018 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: 696 bottles

Product Description

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.

Distribution Pattern

U.S. nationwide

Code Information

RV1604, Exp 09/2019