The Recall Desk
ModerateFDA (Drugs)·D-0043-2019·Announced 2018-10-24

Product Quest Recalls HuMist Saline Nasal Mist Due to Manufacturing Deviations

Product Quest Manufacturing LLC is recalling HuMist Saline Nasal Mist bottles 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 involves a voluntary precautionary recall for CGMP deviations without reported illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Product Quest Manufacturing LLC is voluntarily recalling 3,264 bottles of HuMist Saline Nasal Mist 1.5 FL OZ (45 mL). The product was distributed nationwide in the USA by Scherer Labs International, LLC. The recall includes all lots remaining within their expiration dates.

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 source text does not specify the exact nature of the manufacturing errors or report any illnesses or injuries associated with the product.

Consumers who have purchased this product should stop using it and contact the recalling firm for further instructions or a refund. The product is identified by the UPC 3 02742 68045 9.

The recalled product

Product
HuMist Saline Nasal Mist 1.5 FL OZ (45 mL) bottle, Distributed by: Scherer Labs International, LLC. 330 Carswell Ave., Daytona Beach, FL 32117, UPC 3 02742 68045 9 .
Affected units
3,264

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 →