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Recall Observatory FDA recall evidence

Device 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

Z-2053-2016

November 16, 2015

Class II

Product summary

Firm
Nephron Pharmaceuticals Corp.
Event
Event 73395
Status
Terminated
Classification
Class II
Quantity
11,208 cartons
Official record key
device-enforcement:Z-2053-2016

Official wording

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

Code information: Lot Number N4745A, Exp 09/16

Distribution pattern: 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.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility