The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0030-2019·Announced 2018-10-24

CVS Health Saline Nasal Mist Recalled for Quality Control Issues

Product Quest Manufacturing LLC is recalling CVS Health Sterile Saline Nasal Mist 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 due to CGMP deviations that could impact quality, but the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Product Quest Manufacturing LLC is recalling 529,536 cans of CVS Health Sterile Saline Nasal Mist (sodium chloride) Saline Nasal Moisturizer, 0.9%. The affected products are distributed nationwide in the USA by CVS Pharmacy, Inc. The recall includes three specific package sizes: Net Wt. 1.52 OZ (43 g) can (UPC 0 50428 37079 7, Product #896831), Net Wt. 4.25 OZ (120 g) can (UPC 0 50428 36124 5), and Children's Net Wt. 2 OZ (57 g) can (UPC 0 50428 58685 3, Product #282472). All lots remaining within their expiry dates are affected.

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 FDA has classified this as a Class II recall, which means the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers should stop using the recalled product and check their inventory for the specific UPC codes and product numbers listed above. If you have questions about this recall, contact the recalling firm, Product Quest Manufacturing LLC, or your local CVS Pharmacy for further instructions on disposal or return.

The recalled product

Product
CVS Health, Sterile Saline Nasal Mist (sodium chloride) Saline Nasal Moisturizer, 0.9%, packaged in a) Net Wt. 1.52 OZ (43 g) can UPC 0 50428 37079 7 Product #896831; b) Net Wt. 4.25 OZ (120 g) can UPC 0 50428 36124 5; c) Children's Net Wt. 2 OZ (57 g) can UPC 0 50428 58685 3…
Manufacturer
Product Quest Manufacturing LLC
Category
Drug — Nasal Spray
Hazard
Affected units
529,536

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.

See all 54 products in this recall →

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