The Recall Desk
HighFDA (Drugs)·D-0053-2019·Announced 2018-10-24

Thayers Saline Nasal Spray Recalled for Manufacturing Quality Deviations

Product Quest Manufacturing is recalling Thayers Saline Nasal Spray due to manufacturing conditions that could impact product quality.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source cites CGMP deviations affecting quality without reporting specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Product Quest Manufacturing, LLC is recalling 22,392 bottles of Thayers Natural Remedies, Saline Nasal Spray, Allergy & Sinus Relief, Slippery Elm, 1.5 FL OZ (44 mL). The product is identified by UPC 7 27510 00660 4. The recall covers all lots remaining within their expiry dates.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The source text states that the products were manufactured under conditions that could impact product quality. The agency has classified this recall as Class II.

The product was distributed nationwide in the USA. Consumers should stop using the product and follow instructions from the recalling firm or the FDA regarding disposal or return.

The recalled product

Product
Thayers Natural Remedies, Saline Nasal Spray, Allergy & Sinus Relief, Slippery Elm, 1.5 FL OZ (44 mL) bottle, Distributed By: Product Quest Manufacturing, LLC, 330 Carswell Ave., Daytona Beach, FL 32117, UPC 7 27510 00660 4.
Manufacturer
Product Quest Manufacturing LLC
Category
Drug — Ophthalmic / Nasal
Hazard
Affected units
22,392

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots remaining within expiry.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 54 recalled by Product Quest Manufacturing LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 54 products in this recall →

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