Rexall Sinus Nasal Pump Mist Recalled for Quality Control Issues
Product Quest Manufacturing LLC is recalling Rexall Sinus Nasal Pump 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 due to CGMP deviations that could impact quality, but no specific illnesses or injuries are reported, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Product Quest Manufacturing LLC is recalling Rexall Sinus Nasal Pump Mist, containing Oxymetazoline Hydrochloride 0.05%, in 1 FL OZ (30mL) bottles. The recall is being conducted because the products were manufactured under conditions that could impact product quality, specifically involving Current Good Manufacturing Practice (CGMP) deviations.
The affected product is identified by SKU 00744201. The recall covers all lots remaining within their expiration dates. The product was distributed nationwide in the USA.
Consumers who have this product should stop using it and contact the manufacturer or their point of purchase for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Rexall, Sinus Nasal Pump Mist, (Oxymetazoline Hydrochloride 0.05%), 1 FL OZ (30mL) bottle, SKU 00744201
- Manufacturer
- Product Quest Manufacturing LLC
- Category
- Drug — Nasal Spray
- Hazard
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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