Product Quest Recalls Well at Walgreens Sinus Relief Mist for Quality Issues
Product Quest Manufacturing LLC is recalling Well at Walgreens ULTRA FINE Sinus Relief Mist due to manufacturing deviations 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II. According to the rubric, an FDA Class II recall is assigned a severity score of 4 (Severe), as it indicates a potential for temporary or medically reversible adverse health consequences.
Plain-English summary
Product Quest Manufacturing LLC is voluntarily recalling 361,104 bottles of Well at Walgreens ULTRA FINE Sinus Relief Mist (Oxymetazoline HCl 0.05%). The product is a 0.5 FL OZ (15 mL) nasal decongestant pump mist distributed by Walgreen Co. The recall covers all lots remaining within their expiry dates.
The recall was initiated because the products were manufactured under conditions that could impact product quality, specifically involving Current Good Manufacturing Practice (CGMP) deviations. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The affected product was distributed nationwide in the USA. Consumers should check their home medicine cabinets for this specific product, identified by NDC 0363-7000-01 and UPC 3 11917 18535 4. If found, consumers should stop using the product and contact the recalling firm or their healthcare provider for instructions on disposal or return.
The recalled product
- Product
- Well at Walgreens, ULTRA FINE Sinus Relief Mist (Oxymetazoline HCl 0.05%) bottle, Sinus Reliever, Nasal Decongestant, 12 Hour Pump Mist, 0.5 FL OZ (15 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-7000-01, UPC 3 11917 18535 4.
- Manufacturer
- Product Quest Manufacturing LLC
- Category
- Drug — Nasal Decongestant
- Hazard
- Affected units
- 361,104
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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