Nephron Pharmaceuticals Corp. recalls Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL for Oral Inhalation Only, Rx Only, 25 x 3 mL Sterile Unit-Dos
Recalled October 30, 2013 · FDA recall D-66462-001 · Nephron Pharmaceuticals
Hazard
Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic aseptic process simulation and discovered bacterial growth in a number of media fill vials, exceeding the allowable limit. · FDA Class II
Units
689,568 cartons
Sold at
Nationwide and Puerto Rico
Description
Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic aseptic process simulation and discovered bacterial growth in a number of media fill vials, exceeding the allowable limit.
Product
Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL for Oral Inhalation Only, Rx Only, 25 x 3 mL Sterile Unit-Dose Vials per carton, Manufactured By: Nephron Pharmaceuticals Corporation, Orlando, FL 32811, NDC 0487-9501-25
Manufacturer(s)
Nephron Pharmaceuticals Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →