The Recall Desk
ModerateFDA (Drugs)·D-0054-2019·Announced 2018-10-24

TopCare Saline Nasal Gel Recalled for Manufacturing Quality Deviations

Product Quest Manufacturing LLC is recalling TopCare Saline Nasal Gel with Soothing Aloe due to manufacturing conditions 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 source text indicates a theoretical risk to product quality without reporting specific illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Product Quest Manufacturing LLC is recalling 7,488 tubes of TopCare Saline Nasal Gel with Soothing Aloe, 0.5 OZ (14 g). The product is distributed by Topco Associates LLC in Elk Grove Village, IL, and carries the UPC 0 36800 42146 2.

The recall was initiated because the products were manufactured under conditions that could impact product quality, representing Current Good Manufacturing Practice (CGMP) deviations. The recall covers all lots remaining within their expiry dates.

The product was distributed nationwide in the USA. Consumers should stop using the product and follow instructions from the recalling firm or retailer for disposal or return.

The recalled product

Product
TopCare, Saline Nasal Gel with Soothing Aloe, 0.5 OZ (14 g) tube, Distributed By Topco Associates LLC, Elk Grove Village, IL 60007, UPC 0 36800 42146 2.
Affected units
7,488

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 →