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FDANovember 16, 2015device

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 respirator...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

nephron pharmaceuticalsnephron

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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