Class II
Terminated
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
- Company
- Nephron Pharmaceuticals Corp.
- Recall Initiated
- August 21, 2015
- Posted
- October 21, 2015
- Recall Number
- D-0010-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- a) 85,248 cartons and b) 35,292 cartons
- Firm Location
- Orlando, FL, United States
Reason for Recall
Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process
Distribution
Nationwide
Lot / Code Info
a) Lot D4E20A, exp 3/2016 and b) Lot D4C21A, exp 3/2016
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