Reported Jul 6, 2016 · Terminated
Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials per carton, Rx Only, NDC 0487-9003-60. A…
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?
- Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials per carton, Rx Only, NDC 0487-9003-60. A vial contains sterile, preservation-free, clear, colorless, aqueous solution as labeled for induction of sputum production where specimen collection is indicated. For respiratory therapy, Solium Chloride Inhalation Solution USP, 3% is used in conjunction with a nebulizer
- Lot codes and dates
Lot Number N4745AExp 09/16
- Amount recalled
- 11,208 cartons
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial.
This product could cause temporary or reversible health problems — stop using it.
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