Validus Pharmaceuticals, Inc. recalls Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL, 15 mL bottle, Rx only, Distributed by: Validus Pharmaceuticals, LLC Par…

Recall date

June 15, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1171-2018

FDA classification

Class III

Brand / firm

Validus Pharmaceuticals, Inc.

Sold / distributed

U.S. nationwide

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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