The Recall Desk
ModerateFDA (Drugs)·D-0032-2019·Announced 2018-10-24

CVS Health Sterile Saline Nasal Mist Recalled for Quality Deviations

Product Quest Manufacturing LLC is recalling CVS Health Sterile Saline Nasal Mist due to manufacturing deviations that could impact product quality.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text cites CGMP deviations that could impact quality without reporting specific injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Product Quest Manufacturing LLC is recalling 277,587 cans of CVS Health Sterile Saline Nasal Mist (sodium chloride) Allergy & Sinus Relief, 3.0%, 4.25 OZ (126 g). The product is distributed by CVS Pharmacy, Inc. and is identified by UPC 0 50428 41854 3.

The recall was initiated because the products were manufactured under conditions that could impact product quality, specifically involving Current Good Manufacturing Practice (CGMP) deviations. The recall covers all lots remaining within their expiry dates.

The affected products were distributed nationwide in the USA. Consumers should check their supply of this specific nasal mist and stop using it if it matches the description and UPC provided.

The recalled product

Product
CVS Health, Sterile Saline Nasal Mist (sodium chloride) Allergy & Sinus Relief, 3.0%, 4.25 OZ (126 g) can, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 41854 3.
Affected units
277,587

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 →