The Recall Desk
ModerateFDA (Drugs)·D-0358-2018·Announced 2018-02-21

Sage Products Recalls Toothette Oral Care Swab System Due to Cross-Contamination

Sage Products Inc. is recalling the Toothette Oral Care Short Term Oral Swab System because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.

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, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses, injuries, or fatalities, and the hazard is described as cross-contamination with non-pharmaceutical products without specific pathogen identification, fitting the criteria for a moderate severity score.

Plain-English summary

Sage Products Inc. is recalling the Toothette Oral Care Short Term Oral Swab System with Perox-A-Mint solution. The product contains 20 Toothette Plus Oral Swabs with sodium bicarbonate, a 1.5 fl.oz/44ml bottle of Perox-A-Mint solution, a .5 oz/14g tube of Mouth Moisturizer, a .3 oz./9g tube of Sodium Bicarbonate Mouthpaste, and an Ultra-Soft Toothbrush. The recall involves 2,429 cases of the product.

The recall is being conducted because oral care solutions were manufactured by a third-party supplier on equipment shared with non-pharmaceutical products, resulting in cross-contamination. The affected product was distributed nationwide in the USA and Puerto Rico, as well as in Canada, the United Kingdom, Ireland, the Netherlands, and New Zealand. Specific lot numbers and expiration dates are listed in the recall documentation, including lots 52267, 52278, 52974, 53633, 53661, 53663, 53667, 54107, 55208, 56290, 56815, 57889, 58819, 59332, 60214, 61607, and 62124.

Consumers should check their inventory for the affected lot numbers and expiration dates. If the product is found, consumers should stop using it and contact the manufacturer or refer to the FDA recall notice for instructions on how to return or dispose of the product.

The recalled product

Product
Toothette Oral Care Short Term Oral Swab System with Perox-A- Mint solution. Contains 20 Toothette Plus Oral Swabs with sodium bicarbonate, 1.5 fl.oz/44ml bottle Perox-A-Mint solution, .5 oz/14g tube of Mouth Moisturizer, .3 oz./9g tube of Sodium Bicarbonate Mouthpaste, I Ultra-S
Manufacturer
Sage Products Inc
Category
Drug — Oral Care
Hazard
Affected units
2,429

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 (20)

  • Product Code: 6001
  • Lots: 52267
  • EXP 08/04/2017
  • 52278
  • 52974
  • 09/21/2017
  • 53633
  • 53661
  • 53663
  • 53667
  • EXP 12/06/2017
  • 54107
  • EXP 01/19/2018
  • 55208
  • EXP 04/25/2018
  • 56290
  • EXP 11/19/2017
  • 56815
  • EXP 05/27/2018
  • 57889

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 64 recalled by Sage Products Inc 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 64 products in this recall →

Related recalls

Same manufacturer · Sage Products Inc

See all →

Same hazard · cross contamination

See all →