Recalls / Class II
Class IID-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
- Brand name
- Ipratropium Bromide And Albuterol Sulfate
- Generic name
- Ipratropium Bromide And Albuterol Sulfate
- Active ingredients
- Albuterol Sulfate, Ipratropium Bromide
- Route
- Respiratory (inhalation)
- NDC
- 0487-0201
- FDA application
- ANDA076749
- Affected lot / code info
- a) Lot D4E20A, exp 3/2016 and b) Lot D4C21A, exp 3/2016
Why it was recalled
Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process
Recalling firm
- Firm
- Nephron Pharmaceuticals Corp.
- Manufacturer
- Nephron Pharmaceuticals Corporation
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 4121 SW 34th St, N/A, Orlando, Florida 32811-6475
Distribution
- Quantity
- a) 85,248 cartons and b) 35,292 cartons
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-08-21
- FDA classified
- 2015-10-09
- Posted by FDA
- 2015-10-21
- Terminated
- 2017-02-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0010-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.