Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution recall — FDA D-0010-2016
Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process
Overview of recall records associated with Nephron Pharmaceuticals Corp., including dates, categories and classifications where available.
Classification mix: Class II: 3.
Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process
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,…
Lack of Assurance of Sterility
This page summarizes recall records in which the official source identifies Nephron Pharmaceuticals Corp. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.