Z-2053-2016Class II

Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials per carton, Rx Only, NDC...

Name: Z-2053-2016 Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials per carton, Rx Only, NDC...
Creator: Nephron Pharmaceuticals Corp.
Published: 2015-11-16
License: https://open.fda.gov/license/

Nephron SC, LLC. / initiated 2015-11-16 / Terminated / root cause: manufacturing process

FDA source

Nephron Pharmaceuticals Corp. began a recall of 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... on 2015-11-16. FDA classified it as Class II and gives the reason as "Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2053-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-16
Posted: 2016-06-27
Terminated: 2017-01-09
Recalling firm: Nephron SC, LLC.
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
Product code: CAF Nebulizer (Direct Patient Interface)
Reason for recall: Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial.
Root cause tag: manufacturing process
FDA root 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.
Product codes and lots: Lot Number N4745A, Exp 09/16

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2053-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2053-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-27
Z-2054-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-27

Product code CAF

K120051Class IISodium Chloride Inhalation Solution, 3%, 7%, and 10%, Usp-4MlNephron Pharmaceuticals Corp. / cleared 2012-04-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)