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
Reason for recall: Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process
Recall initiated: 20150821
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated