Reported Oct 21, 2015 · Terminated
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, packaged in 30x3 mL Sterile Unit-Dose Vials,…
Nephron Pharmaceuticals Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nephron Pharmaceuticals Corp. · 4121 SW 34th St · Orlando, FL · 32811-6475
Is this the product you have?
- 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
- Lot codes and dates
a) Lot D4E20Aexp 3/2016 and b) Lot D4C21Aexp 3/2016
- Amount recalled
- a) 85,248 cartons and b) 35,292 cartons
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process
This product could cause temporary or reversible health problems — stop using it.
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