Sodium Chloride Inhalation Solution recalled over sterility concerns

Recall date

November 16, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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. A…

Recall number

Z-2053-2016

FDA classification

Class II

Brand / firm

Nephron Pharmaceuticals Corp.

Sold / distributed

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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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