FDA recall D-1427-2014

Boehringer Ingelheim Roxane Inc · Class II · drug

Product

Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41.

Reason for recall

Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2014-05-01
Report date
2014-07-16
Termination date
2015-04-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1427-2014