FDA Recalls Premier Value Nasal Spray Due to Manufacturing Deviations
Product Quest Manufacturing LLC is recalling Premier Value Nasal Decongestant Extra Moisturizing Nasal Spray because it was manufactured under conditions 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, which typically involves a reasonable probability of temporary or medically reversible adverse health consequences. The source cites CGMP deviations that could impact quality but does not report specific illnesses or injuries, aligning with a Moderate severity rating for a voluntary precautionary recall.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Premier Value Nasal Decongestant Extra Moisturizing Nasal Spray (Oxymetazoline HCl 0.05%), 1 FL OZ (30 mL) bottles. The product is distributed by Chain Drug Consortium and manufactured by Product Quest Manufacturing LLC. The recall involves 8,592 bottles with NDC 68016-304-03 and UPC 8 40986 01518 2.
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 covers all lots remaining within their expiry dates.
The product was distributed nationwide in the USA. Consumers who have this product should stop using it and contact the distributor or manufacturer for further instructions.
The recalled product
- Product
- Premier Value Nasal Decongestant Extra Moisturizing Nasal Spray (Oxymetazoline HCl 0.05%), 1 FL OZ (30 mL) bottle, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 68016-304-03, UPC 8 40986 01518 2.
- Manufacturer
- Product Quest Manufacturing LLC
- Category
- Drug — Nasal Spray
- Hazard
- Affected units
- 8,592
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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