Reported Oct 30, 2013 · Terminated
Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL for Oral Inhalation Only, Rx Only, 25 x 3 mL Sterile…
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?
- Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL for Oral Inhalation Only, Rx Only, 25 x 3 mL Sterile Unit-Dose Vials per carton
- Manufactured ByNephron Pharmaceuticals Corporation, Orlando, FL 32811, NDC 0487-9501-25
- Lot codes and dates
Lots #: A3A33AA3A33BA3A34AA3A35A. A3A36AA3A37AA3A38AExp 06/15A3A40AA3A41AA3A42AExp 07/15
- Amount recalled
- 689,568 cartons
Where it was sold
- Nationwide
- PR
Why it was recalled
Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic aseptic process simulation and discovered bacterial growth in a number of media fill vials, exceeding the allowable limit.
This product could cause temporary or reversible health problems — stop using it.
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