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FDAJune 15, 2018drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

validus pharmaceuticalsvalidus

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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