Drug recall D-0010-2016
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
Lots and codes
a) Lot D4E20A, exp 3/2016 and b) Lot D4C21A, exp 3/2016
Recall details
- Recalling firm
- Nephron Pharmaceuticals Corp., Orlando, FL
- Quantity
- a) 85,248 cartons and b) 35,292 cartons
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 21, 2015
- Terminated
- February 10, 2017
Related products
- Ipratropium Bromide and Albuterol Sulfate – drug information
- NDC 0487-0201 Ipratropium Bromide and Albuterol Sulfate · Ipratropium Bromide .5 mg/3mL; Albuterol Sulfate 3 mg/3mL · Nephron Pharmaceuticals Corporation