The Recall Desk
ModerateFDA (Drugs)·D-0048-2019·Announced 2018-10-24

Premier Value Saline Nasal Spray Recalled for Quality Concerns

Product Quest Manufacturing LLC is recalling Premier Value Saline Nasal Spray due to manufacturing deviations that could impact product quality.

What this means for you

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 hazard involves potential quality impacts from manufacturing deviations without reported illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Product Quest Manufacturing LLC is recalling 102,348 bottles of Premier Value Saline Nasal Spray, Sodium Chloride 0.65%. The affected products are distributed nationwide in the USA by Chain Drug Consortium. The recall includes 3 FL OZ (88 mL) bottles (NDC 68016-388-00) and 1.5 FL OZ (44 mL) bottles (NDC 68016-466-00). All lots remaining within their expiry dates are affected.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The source text states that the products were manufactured under conditions that could impact product quality. No specific illnesses, injuries, or deaths are reported in the source text.

Consumers should stop using the recalled product and return it to the place of purchase for a refund or follow instructions provided by the recalling firm.

The recalled product

Product
Premier Value, Saline Nasal Spray, Sodium Chloride 0.65%, packaged as a) 3 FL OZ (88 mL) bottle NDC 68016-388-00 UPC 8 40986 01483 3; b) 1.5 FL OZ (44 mL) bottle NDC 68016-466-00 UPC 8 40986 01482 6, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca R
Manufacturer
Product Quest Manufacturing LLC
Category
Drug — Nasal Spray
Hazard
Affected units
102,348

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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