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

Agency Publication Date: June 27, 2016

Affected Products

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

Lot Number N4745A, Exp 09/16

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Product: Sodium Chloride Inhalation Solution, USP 7%, 60 x 4 mL Sterile Unit-Dose Vials, Rx Only, NDC 0487-9007-60. 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

Lot Number N4753A, Exp 11/16

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Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 73395

Status: Resolved

Manufacturer: Nephron Pharmaceuticals Corp.

Manufactured In: United States

Units Affected: 2 products (11,208 cartons; 13,692 cartons)

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Sources: FDA iRES · Raw API Response

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Affected Products

Lot Number N4745A, Exp 09/16

Lot Numbers:

Number

Lot Number N4753A, Exp 11/16

Lot Numbers:

Number