CLASS II Drug recall · Reported 24 Oct 2018 · FDA Enforcement Report

Premier Value, Sterile Saline Nasal Mist recalled

Product Quest Manufacturing is recalling Premier Value, Sterile Saline Nasal Mist, Saline Nasal Moisturizer (0.9% Sodium Chloride), distributed nationwide in the US. The recall was initiated on 3 Aug 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots remaining within expiry.

Quantity recalled10,584 cans

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0046-2019
FDA event ID: 80750
Recalling firm: Product Quest Manufacturing, Daytona Beach, FL
Classification: Class II
Status: Terminated
Recall initiated: 3 Aug 2018
FDA classified: 16 Oct 2018
Reported: 24 Oct 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Manufacturing (CGMP) Deviations
Drug class: Nasal Sprays

Timeline

3 Aug 2018	Recall initiated by company
16 Oct 2018	Classified by FDA	+74 days
24 Oct 2018	Published in enforcement report	+8 days

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

Reason for recall

CGMP Deviations: products manufactured under conditions that could impact its product quality.

Product as listed by the FDA

Premier Value, Sterile Saline Nasal Mist, Saline Nasal Moisturizer (0.9% Sodium Chloride) Solution, 4.25 FL OZ (126 mL) can, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 8 40986 02998 1.

Where it was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Why was it recalled?

CGMP Deviations: products manufactured under conditions that could impact its product quality.

Which lots are affected?

All lots remaining within expiry.

Where was it sold?

Nationwide in the USA

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

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

53 other products · FDA event 80750

This product is part of a recall event; the main page for the event is Thayers Natural Remedies, Saline Nasal Spray recalled.

Reported	Class	Recall	Company	Reason	Where
24 Oct 2018	CLASS II	Thayers Natural Remedies, Saline Nasal Spray recalled	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide
24 Oct 2018	CLASS II	Premier Value, Saline Nasal Spray, Sodium Chloride recalled	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide
24 Oct 2018	CLASS II	QC Quality Choice, Saline Nasal Gel with Soothing Aloe tube recalled	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide
24 Oct 2018	CLASS II	Best Choice, 12 Hour Extra Moisturizing, Nasal Spray recalled	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide
24 Oct 2018	CLASS III	Well at Walgreens, Scar Cream with SPF 30, (Avobenzone recalled	Product Quest Manufacturing	Potency & Assay	Nationwide
24 Oct 2018	CLASS II	Rexall, Extra Moisturizing No Drip Nasal Spray recalled	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide
24 Oct 2018	CLASS II	Finafta Baby, Oral Gel (benzocaine 7.5%) tube recalled	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide
24 Oct 2018	CLASS II	TopCare, Saline Nasal Gel with Soothing Aloe tube recalled	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide
24 Oct 2018	CLASS II	CVS Health, Sterile Saline Nasal Mist recalled	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide
24 Oct 2018	CLASS II	Family Dollar Saline Nasal Spray recalled by Product Quest Manufacturing	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide
24 Oct 2018	CLASS III	Cicatricure, Scar Cream + Sunscreen SPF 30 (avobenzone recalled	Product Quest Manufacturing	Potency & Assay	Nationwide
24 Oct 2018	CLASS I	Sinus Relief (oxymetazoline HCl) Nasal decongestant recalled	Product Quest Manufacturing	Sterility	Nationwide
24 Oct 2018	CLASS II	Mushatt's No. 9, PsoriWash Medicated Wash, Salicylic Acid 1.8% tube recalled	Product Quest Manufacturing	Sterility	Nationwide
24 Oct 2018	CLASS II	QC Quality Choice, Saline Nasal Relief recalled	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide
24 Oct 2018	CLASS II	Harmon Face Values, Saline Nasal Spray (sodium chloride) recalled	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide
24 Oct 2018	CLASS II	meijer, Saline Nasal Spray, Nasal Moisturizing Spray, packaged as a) recalled	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide
24 Oct 2018	CLASS II	Walgreens, NO DRIP Severe Anefrin Nasal Spray recalled	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide
24 Oct 2018	CLASS II	CVS Health, Sterile Saline Nasal Mist recalled	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide
24 Oct 2018	CLASS II	Family wellness, Sterile Saline, Nasal Mist recalled	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide
24 Oct 2018	CLASS II	Rexall, Extra Moisturizing No Drip Nasal Spray recalled	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide
24 Oct 2018	CLASS II	Meijer, Sterile Saline Nasal Mist (0.9% Sodium Chloride Solution) recalled	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide
24 Oct 2018	CLASS II	CVS Health, Saline Nasal Spray, Nasal Moisturizing Spray recalled	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide
24 Oct 2018	CLASS II	Rhinall Nasal Decongestant Nasal Spray (phenylephrine HCl) recalled	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide
24 Oct 2018	CLASS II	Premier Value, Fast Relief, Muscle Rub, (menthol recalled	Product Quest Manufacturing	Potency & Assay	Nationwide
24 Oct 2018	CLASS II	Ocean Saline Nasal Spray recalled by Product Quest Manufacturing	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide
24 Oct 2018	CLASS II	CVS Health, Saline Nasal Gel with Soothing Aloe, packaged as a) Baby recalled	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide
24 Oct 2018	CLASS II	CeraVe Healing Lip Balm/SPF 30 (avobenzone recalled	Product Quest Manufacturing	Sterility	Nationwide
24 Oct 2018	CLASS II	DG health, No Drip, Nasal Pump Mist recalled	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide
24 Oct 2018	CLASS II	HuMist Saline Nasal Mist recalled by Product Quest Manufacturing	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide
24 Oct 2018	CLASS II	Premier Value, Nasal Decongestant, Nasal Spray recalled	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide
24 Oct 2018	CLASS II	dr. brandt, BB cream with signature Flexitone, SPF 30 tube recalled	Product Quest Manufacturing	Potency & Assay	Nationwide
24 Oct 2018	CLASS II	Rite Aid Pharmacy, First Aid Antibiotic Ointment recalled	Product Quest Manufacturing	Potency & Assay	Nationwide
24 Oct 2018	CLASS II	Dermatone (titanium oxide recalled by Product Quest Manufacturing	Product Quest Manufacturing	Other Bacterial Contamination	Nationwide
24 Oct 2018	CLASS II	Walgreens, NO DRIP, Anefrin Nasal Spray recalled	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide
24 Oct 2018	CLASS II	Walgreens, Nasal Spray (Oxymetazoline HCl 0.05%) Nasal recalled	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide
24 Oct 2018	CLASS II	Discount Drug Mart, Food Fair, Saline Nasal Spray recalled	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide
24 Oct 2018	CLASS II	Freeze IT (camphor 0.2% and menthol 3.5%) spray recalled	Product Quest Manufacturing	Potency & Assay	Nationwide
24 Oct 2018	CLASS II	Thayers Natural Remedies, Saline Nasal Mist recalled	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide
24 Oct 2018	CLASS II	Rexall, Sinus Nasal Pump Mist, (Oxymetazoline Hydrochloride 0.05%) recalled	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide
24 Oct 2018	CLASS II	Premier Value, Nasal Decongestant, No Drip Nasal Spray recalled	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide
24 Oct 2018	CLASS II	CVS Health, Baby Nasal Spray/Drops, Non-Medicated recalled	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide
24 Oct 2018	CLASS II	Best Choice, 12 Hour Sinus Relief, Nasal Spray recalled	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide
24 Oct 2018	CLASS II	Walgreens, NO DRIP Anefrin Nasal Spray recalled	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide
24 Oct 2018	CLASS II	CareOne, Saline Nasal Gel With Soothing Aloe recalled	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide
24 Oct 2018	CLASS II	Harmon Face Values, Saline Nasal Gel with Soothing Aloe tube recalled	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide
24 Oct 2018	CLASS II	Best Choice, 12 Hour No-Drip Nasal Spray recalled	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide
24 Oct 2018	CLASS II	Premier Value Nasal Decongestant Extra Moisturizing Nasal recalled	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide
24 Oct 2018	CLASS II	Best Choice, Saline Nasal Spray recalled by Product Quest Manufacturing	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide
24 Oct 2018	CLASS II	Well at Walgreens, Ultra Fine Sinus Relief Mist recalled	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide
24 Oct 2018	CLASS II	Rite Aid Pharmacy, nasal relief NO Drip Pump Spray nasal recalled	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide
24 Oct 2018	CLASS II	CVS Health, Original Strength recalled by Product Quest Manufacturing	Product Quest Manufacturing	Potency & Assay	Nationwide
24 Oct 2018	CLASS II	Rhinall (phenylephrine hydrochloride) Nasal Decongestant recalled	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide
24 Oct 2018	CLASS II	CVS Health, Saline Nasal Spray recalled by Product Quest Manufacturing	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide

More recalls from Product Quest Manufacturing

All 54

Reported	Class	Recall	Company	Reason	Where
24 Oct 2018Drug	CLASS II	CVS Health, Saline Nasal Spray recalled by Product Quest Manufacturing	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide
24 Oct 2018Drug	CLASS II	Rhinall (phenylephrine hydrochloride) Nasal Decongestant recalled	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide
24 Oct 2018Drug	CLASS II	CVS Health, Original Strength recalled by Product Quest Manufacturing	Product Quest Manufacturing	Potency & Assay	Nationwide
24 Oct 2018Drug	CLASS II	Rite Aid Pharmacy, nasal relief NO Drip Pump Spray nasal recalled	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide
24 Oct 2018Drug	CLASS II	Well at Walgreens, Ultra Fine Sinus Relief Mist recalled	Product Quest Manufacturing	Manufacturing (CGMP) Deviations	Nationwide