FDA recall D-1446-2012

Nephron Pharmaceuticals Corp. · Class II · drug

Product

Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose Vials, 60-count (60 x 3 mL Sterile Unit-Dose Vials) per carton, Rx only, Manufactured by: nephron pharmaceuticals corporation, Orlando, FL 32811, NDC 0487-9501-60.

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2011-06-22
Report date: 2012-08-15
Termination date: 2012-11-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Orlando, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1446-2012