FDA recall D-1170-2018

Validus Pharmaceuticals, Inc. · Class III · drug

Product

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

Reason for recall

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

Distribution

U.S. nationwide

Key facts

Status
Terminated
Initiation date
2018-06-15
Report date
2018-09-05
Termination date
2021-01-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Parsippany, NJ, United States

Primary source

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