Recall Z-2053-2016— Nephron Pharmaceuticals Corp.

Name: FDA recall Z-2053-2016
Creator: U.S. Food and Drug Administration
Published: 2015-11-16

Class II · Terminated

Class II FDA medical device recall by Nephron Pharmaceuticals Corp., initiated 2015-11-16, terminated 2017-01-09. It names one FDA 510(k) clearance: K120051. 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. Reason: Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial..

Recalling firm: Nephron Pharmaceuticals Corp.
Classification: Class II
Status: Terminated
Initiated: 2015-11-16
Terminated: 2017-01-09
Firm location: Orlando, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K120051 — SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4MLNephron Pharmaceuticals Corp.·cleared 2012-04-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.