Nephron Pharmaceuticals Corp. recalls Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, packaged in 30x3 mL Sterile Unit-Dose Vials,
Recalled October 21, 2015 · FDA recall D-0010-2016 · Nephron Pharmaceuticals
Hazard
Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process · FDA Class II
Units
a) 85,248 cartons and b) 35,292 cartons
Sold at
Nationwide
Description
Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process
Product
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, packaged in 30x3 mL Sterile Unit-Dose Vials, a) 30 count (NDC 0487-0201-03) and b) 60 count (NDC 0487-0201-60) vials per carton, Rx only, Nephron Pharmaceutical Corporation, Orlando, FL
Manufacturer(s)
Nephron Pharmaceuticals Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →