CVS Health Saline Nasal Spray Recalled for Manufacturing Deviations
Product Quest Manufacturing LLC is recalling 552 bottles of CVS Health Saline Nasal Spray due to CGMP deviations that could impact product quality.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source text cites CGMP deviations impacting quality without reporting specific injuries or illnesses, aligning with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Product Quest Manufacturing LLC is recalling 552 bottles of CVS Health Saline Nasal Spray, Nasal Moisturizing Spray. The product is a 1.5 FL OZ (44 mL) bottle containing Sodium Chloride 0.65%, Benzyl Alcohol, and Benzalkonium Chloride as preservatives. It is distributed by CVS Pharmacy, Inc. and identified by UPC 0 50428 40814 8 and Product #891465.
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 agency has classified this recall as Class II.
The affected product was distributed nationwide in the USA. Consumers should check their inventory for this specific product and lot information. If found, consumers should stop using the product and follow instructions from the recalling firm or the FDA regarding disposal or return.
The recalled product
- Product
- CVS Health, Saline Nasal Spray, Nasal Moisturizing Spray, Contains: Sodium Chloride 0.65%, Benzyl Alcohol & Benzalkonium Chloride as Preservatives, 1.5 FL OZ (44 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 40814 8 Product #8914
- Manufacturer
- Product Quest Manufacturing LLC
- Category
- Drug — Nasal Spray
- Affected units
- 552
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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