FDA-Drug2015-10-21Class II
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
Nephron Pharmaceuticals Corp.
Hazard
Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process
Sold states
Nationwide
Affected count
a) 85,248 cartons and b) 35,292 cartons
Manufactured in
4121 SW 34th St, N/A, Orlando, FL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0010-2016Don't want to check this manually?
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