FDA recall D-0388-2016

Nephron Pharmaceuticals Corp. · Class II · drug

Product

Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator, Starter Kit (Racepinephrine 11.25 mg) 10 individual foil wrapped vials with 1 EZ Breathe Atomizer per carton, Manufactured By: nephron pharmaceuticals corporation, Orlando, FL --- NDC 0487-2784-10

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-0388-2016