Harmon Face Values Saline Nasal Gel Recalled for Quality Deviations
Product Quest Manufacturing LLC is recalling Harmon Face Values Saline Nasal Gel with Soothing Aloe 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 source text explicitly identifies the recall as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), as the agency's own classification mandates a minimum score of 4.
Plain-English summary
Product Quest Manufacturing LLC is recalling 5,040 tubes of Harmon Face Values, Saline Nasal Gel with Soothing Aloe, 0.5 oz. (14.1 g). The product is distributed by Harmon Stores, Inc., in Union, NJ, and carries UPC 7 27510 00474 7. 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 as a Class II recall.
The product was distributed nationwide in the USA. Consumers should stop using the product and contact the distributor or manufacturer for further instructions.
The recalled product
- Product
- Harmon Face Values, Saline Nasal Gel with Soothing Aloe, 0.5 oz. (14.1 g) tube, Distributed by: Harmon Stores, Inc., Union, NJ 07083 USA, UPC 7 27510 00474 7 .
- Manufacturer
- Product Quest Manufacturing LLC
- Category
- Drug — Nasal Gel
- Hazard
- Affected units
- 5,040
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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