FDA-Drug2018-09-05Class III

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

Validus Pharmaceuticals, Inc.
Hazard

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

Sold states
U.S. nationwide
Affected count
696 bottles
Manufactured in
119 Cherry Hill Rd Ste 310, N/A, Parsippany, NJ, United States
Products
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 notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1171-2018

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