FDA-Drug2018-09-05Class III

Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA, NDC 63304-241-59

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
7864 bottles
Manufactured in
119 Cherry Hill Rd Ste 310, N/A, Parsippany, NJ, United States
Products
Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA, NDC 63304-241-59

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1170-2018

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