Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Sodium Chloride Inhalation Solution Recalled by Nephron Pharmaceuticals Corp. Due to Lack of Assurance of Sterility: Internal dye ingress...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Nephron Pharmaceuticals Corp. directly.
Affected Products
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
Quantity: 11,208 cartons
Why Was This Recalled?
Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial.
Where Was This Sold?
This product was distributed to 35 states: AL, AZ, AR, CA, CO, CT, FL, GA, IL, KY, LA, MA, MI, MN, MS, MO, NE, NH, NJ, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, UT, VT, VA, WA, WV, WI
About Nephron Pharmaceuticals Corp.
Nephron Pharmaceuticals Corp. has 10 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report