Recalls / Class II
Class IID-0388-2016
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
- Affected lot / code info
- Lots R4027A (Exp 10/31/2015), R4036A (Exp 12/31/2015)
Why it was recalled
Discoloration
Recalling firm
- Firm
- Nephron Pharmaceuticals Corp.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 4121 SW 34th St, Orlando, Florida 32811-6475
Distribution
- Quantity
- 47,754 cartons
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-08-21
- FDA classified
- 2015-11-27
- Posted by FDA
- 2015-12-09
- Terminated
- 2017-02-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0388-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.