FDA recall D-1171-2018

Validus Pharmaceuticals, Inc. · Class III · drug

Product

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

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-1171-2018