Product Quest Recalls CareOne Saline Nasal Gel Due to Quality Concerns
Product Quest Manufacturing LLC is recalling CareOne Saline Nasal Gel With Soothing Aloe 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 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 source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall must be scored as 4 (Severe), regardless of the absence of reported injuries.
Plain-English summary
Product Quest Manufacturing LLC is voluntarily recalling 4,464 tubes of CareOne Saline Nasal Gel With Soothing Aloe, Net Wt. 0.5 OZ (14.1 g). The product is distributed by Foodhold U.S.A., LLC., and is identified by UPC 3 41520 00175 8. The recall covers all lots remaining within their expiry dates.
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 agency has classified this recall as Class II.
The affected product was distributed nationwide in the USA. Consumers who have this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- CareOne, Saline Nasal Gel With Soothing Aloe, Net Wt. 0.5 OZ (14.1 g) tube, Distributed by Foodhold U.S.A., LLC., Landover, MD 20785, 1-877-846-9949, UPC 3 41520 00175 8.
- Manufacturer
- Product Quest Manufacturing LLC
- Category
- Drug — Nasal Gel
- Hazard
- Affected units
- 4,464
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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