Class 2 Device Recall Sodium Chloride Inhalation Solution

• Date Initiated by Firm: November 16, 2015
• Date Posted: June 27, 2016
• Recall Status: Terminated on January 09, 2017
• Recall Number: Z-2053-2016
• Recall Event ID: 73395
• 510(K)Number: K120051
• Product Classification: Nebulizer (direct patient interface) - Product Code CAF
• 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
• Code Information: Lot Number N4745A, Exp 09/16
• Recalling Firm/ Manufacturer: Nephron Pharmaceuticals Corp.; 4121 SW 34th St; Orlando FL 32811-6475
• For Additional Information Contact: Audrey Smith; 800-443-4313
• Manufacturer Reason for Recall: Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial.
• FDA Determined Cause: Process control
• Action: Nephron Pharmaceuticals Corporation sent an Urgent Drug Recall letter to all affected customers on November 16, 2015. The letter identified the product, the problem, and the action to be taken by the customer. NPC requested customers remove the affected lots from their inventory, including store shelves. Customers with questions should call 1-844-374-6841
• Quantity in Commerce: 11,208 cartons
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = CAF