Validus Pharmaceuticals, Inc. recalls Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL, 15 mL bottle, Rx only, Distributed by: Validus Pharmaceuticals, LLC Pars
Recalled September 5, 2018 · FDA recall D-1171-2018 · Validus Pharmaceuticals
Hazard
Subpotency: lower than expected potency result was obtained at the 18 month stability time point. · FDA Class III
Units
696 bottles
Sold at
U.S. nationwide
Description
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
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
Manufacturer(s)
Validus Pharmaceuticals, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →