Drug 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
D-0010-2016
Product summary
- Event
- Event 72099
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 85,248 cartons and b) 35,292 cartons
- Official record key
drug-enforcement:D-0010-2016
Official wording
Reason: Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process
Code information: a) Lot D4E20A, exp 3/2016 and b) Lot D4C21A, exp 3/2016
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility