FDA-Drug2013-10-30Class II
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
Nephron Pharmaceuticals Corp.
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.
Sold states
Nationwide and Puerto Rico
Affected count
689,568 cartons
Manufactured in
4121 SW 34th St, N/A, Orlando, FL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-66462-001Don't want to check this manually?
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