CLASS II Device recall · Reported 6 Jul 2016 · FDA Enforcement Report

Sodium Chloride Inhalation Solution recalled by Nephron Pharmaceuticals

Nephron Pharmaceuticals is recalling Sodium Chloride Inhalation Solution, USP 7%, mL Sterile Unit-Dose Vials, distributed in 36 states. The recall was initiated on 16 Nov 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number N4753A, Exp 11/16

Quantity recalled13,692 cartons

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2054-2016
FDA event ID: 73395
Recalling firm: Nephron Pharmaceuticals, Orlando, FL
Classification: Class II
Status: Terminated
Recall initiated: 16 Nov 2015
FDA classified: 27 Jun 2016
Reported: 6 Jul 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: CPAP & Ventilators

Timeline

16 Nov 2015	Recall initiated by company
27 Jun 2016	Classified by FDA	+224 days
6 Jul 2016	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

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.

Alabama Arkansas Arizona California Colorado Connecticut Florida Georgia Illinois Kentucky Louisiana Massachusetts Michigan Minnesota Missouri Mississippi North Carolina North Dakota Nebraska New Hampshire

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lot Number N4753A, Exp 11/16

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 73395

This product is part of a recall event; the main page for the event is Sodium Chloride Inhalation Solution recalled by Nephron Pharmaceuticals.

Reported	Class	Recall	Company	Reason	Where
6 Jul 2016	CLASS II	Sodium Chloride Inhalation Solution recalled by Nephron Pharmaceuticals	Nephron Pharmaceuticals	Sterility	36 states

More recalls from Nephron Pharmaceuticals

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