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U.S. Department of Health and Human Services

Class 2 Device Recall Sodium Chloride Inhalation Solution

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  Class 2 Device Recall Sodium Chloride Inhalation Solution see related information
Date Initiated by Firm November 16, 2015
Date Posted June 27, 2016
Recall Status1 Terminated 3 on January 09, 2017
Recall Number Z-2054-2016
Recall Event ID 73395
510(K)Number K120051  
Product Classification Nebulizer (direct patient interface) - Product Code CAF
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
Code Information Lot Number N4753A, Exp 11/16
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 2		 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 13,692 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 and Original Applicant = NEPHRON PHARMACEUTICALS CORP.
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