CVS Health Baby Nasal Spray Recalled for Manufacturing Quality Deviations
Product Quest Manufacturing LLC is recalling CVS Health Baby Nasal Spray/Drops due to manufacturing 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 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 a theoretical risk to product quality without reporting specific illnesses or injuries, aligning with the criteria for a moderate severity score.
Plain-English summary
Product Quest Manufacturing LLC is recalling 42,792 bottles of CVS Health, Baby Nasal Spray/Drops, Non-Medicated, 0.5 FL OZ (15 mL). The product is distributed by CVS Pharmacy, Inc. and carries UPC 0 50428 29380 5 and Product #459367.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The source text indicates that the products were manufactured under conditions that could impact product quality. The recall covers all lots remaining within their expiry dates.
The affected product was distributed nationwide in the USA. Consumers should check their supply of this specific product and follow instructions from the recalling firm or their healthcare provider regarding disposal or return.
The recalled product
- Product
- CVS Health, Baby Nasal Spray/Drops, Non-Medicated, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 29380 5 Product #459367.
- Manufacturer
- Product Quest Manufacturing LLC
- Category
- Drug — Nasal Spray
- Affected units
- 42,792
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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