FDA recall D-0389-2016

Nephron Pharmaceuticals Corp. · Class II · drug

Product

Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator Refills (Racepinephrine USP 11.25 mg), 30 individual foil wrapped vials per carton, Manufactured By: nephron pharmaceuticals corporation, Orlando, FL --- NDC 0487-2784-01

Reason for recall

Discoloration

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2015-08-21
Report date
2015-12-09
Termination date
2017-02-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Orlando, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0389-2016