Product Quest Recalls QC Quality Choice Saline Nasal Spray for CGMP Deviations
Product Quest Manufacturing LLC is recalling QC Quality Choice Saline Nasal Spray 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 2/5 (Moderate).
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, and the source text describes manufacturing deviations that could impact quality without reporting specific illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Product Quest Manufacturing LLC is recalling QC Quality Choice, Saline Nasal Relief, Moisturizing Nasal Spray, Sodium Chloride 0.65%. The product is distributed by C.D.M.A., Inc. and is available in 1.5 FL OZ (45 mL) and 3 FL OZ (89 mL) bottles. The recall covers 172,800 bottles distributed nationwide in the USA.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. These deviations indicate that the products were manufactured under conditions that could impact product quality. The recall includes all lots remaining within their expiry dates.
Consumers who have purchased this product should stop using it and return it to the place of purchase for a refund or contact the recalling firm for further instructions.
The recalled product
- Product
- QC Quality Choice, Saline Nasal Relief, Moisturizing Nasal Spray, Sodium Chloride 0.65%, packaged as a) 1.5 FL OZ (45 mL) bottle UPC 6 35515 98845 3; b) 3 FL OZ (89 mL) bottle UPC 6 35515 95042 9, Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376-0995.
- Manufacturer
- Product Quest Manufacturing LLC
- Category
- Drug — Nasal Spray
- Affected units
- 172,800
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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