FDA Recalls Premier Value Nasal Decongestant Spray Due to Quality Concerns
Product Quest Manufacturing LLC is recalling Premier Value Nasal Decongestant Nasal Spray because it was 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 due to CGMP deviations that could impact quality, but no specific illnesses or injuries are reported, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Premier Value, Nasal Decongestant, Nasal Spray (oxymetazoline HCl 0.05%), Regular Strength, 1 FL OZ (30 mL) bottles. The product is distributed by Chain Drug Consortium and manufactured by Product Quest Manufacturing LLC. The recall involves 4,992 bottles distributed nationwide in the USA.
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.
Consumers who have purchased this product should stop using it and return it to the place of purchase for a refund or contact the recalling firm for further instructions. The FDA classifies this as a Class II recall, indicating a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Premier Value, Nasal Decongestant, Nasal Spray (oxymetazoline HCl 0.05%), Regular Strength, 1 FL OZ (30 mL) bottle, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 68016-316-03, UPC 8 40986 01516 8.
- Manufacturer
- Product Quest Manufacturing LLC
- Category
- Drug — Nasal Spray
- Hazard
- Affected units
- 4,992
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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