Rhinall Nasal Decongestant Recalled for Manufacturing Quality Deviations
Product Quest Manufacturing LLC is recalling Rhinall nasal drops due to CGMP 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 moderate severity involving potential but not confirmed harm.
Plain-English summary
Product Quest Manufacturing LLC is recalling Rhinall (phenylephrine hydrochloride) Nasal Decongestant Nose Drops, 0.25%, 1 FL OZ (30 mL) bottles. The recall involves 4,040 bottles distributed nationwide in the USA by Scherer Labs International, LLC. 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 UPC 3 02747 52531 1. All lots remaining within their expiry dates are included in this recall. No specific lot numbers are listed in the source text, so consumers should check their bottles for the distributor information and UPC code.
Consumers who have purchased this product should stop using it and contact the recalling firm or their point of purchase for a refund or replacement. The FDA classifies this recall as Class II, indicating a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Rhinall (phenylephrine hydrochloride) Nasal Decongestant Nose Drops, 0.25%, 1 FL OZ (30 mL) bottle, Distributed by: Scherer Labs International, LLC., 330 Carswell Ave., Daytona Beach, FL 32117, UPC 3 02747 52531 1.
- Manufacturer
- Product Quest Manufacturing LLC
- Category
- Drug — Nasal Decongestant
- Hazard
- Affected units
- 4,040
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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