Nephron Pharmaceuticals Corp. recalls Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials per carton, Rx Only, NDC 0487-9003-60.

Recalled July 6, 2016 · FDA recall Z-2053-2016 · Nephron Pharmaceuticals

Hazard

Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial. · FDA Class II

Units

11,208 cartons

Sold at

Worldwide Distribution - US including AL, AR, AZ, CA, CO, CT, FL, GA, IL, KY, LA, MA, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI, WV and Internationally to Canada.

Description

Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial.

Product

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

Manufacturer(s)

Nephron Pharmaceuticals Corp.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →