Product Quest Recalls Saline Nasal Mist Due to Manufacturing Deviations
Product Quest Manufacturing LLC is recalling 46,056 cans of FAMILY wellness Sterile Saline Nasal Mist because they were manufactured under conditions that could impact product quality.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 does not report any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Product Quest Manufacturing LLC is recalling 46,056 cans of FAMILY wellness, Sterile Saline, Nasal Mist, Saline Nasal Relief (0.9% Sodium Chloride Solution), 4.25 FL OZ (126 mL) can. The product is distributed by Midwood Brands, LLC, and carries the UPC 0 32251 11617 9.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the products were manufactured under conditions that could impact product quality. The recall includes all lots remaining within their expiry dates.
The affected product was distributed nationwide in the USA. Consumers should check their homes for this product and stop using it if found.
The recalled product
- Product
- FAMILY wellness, Sterile Saline, Nasal Mist, Saline Nasal Relief (0.9% Sodium Chloride Solution), 4.25 FL OZ (126 mL) can, Distributed by: Midwood Brands, LLC, 10611 Monroe Rd., Matthews, NC 28105, UPC 0 32251 11617 9.
- Manufacturer
- Product Quest Manufacturing LLC
- Category
- Drug — Saline Nasal Spray
- Hazard
- Affected units
- 46,056
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.
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