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
Reported: October 21, 2015 Initiated: August 21, 2015 #D-0010-2016
Product Description
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
Details
- Recalling Firm
- Nephron Pharmaceuticals Corp.
- Units Affected
- a) 85,248 cartons and b) 35,292 cartons
- Distribution
- Nationwide
- Location
- Orlando, FL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Nephron Pharmaceuticals Corp.. Units affected: a) 85,248 cartons and b) 35,292 cartons.
Why was this product recalled? ▼
Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 21, 2015. Severity: Moderate. Recall number: D-0010-2016.
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