The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0355-2018·Announced 2018-02-21

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

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

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, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences. The hazard is a theoretical risk of cross-contamination with non-pharmaceutical products, and no specific illnesses or injuries are reported in the source text.

Plain-English summary

Sage Products Inc. is voluntarily recalling the Toothette Short Term Oral Swab System with Perox-A-Mint Solution. The recall involves 966 cases of the product, which includes 20 individually wrapped Toothette Plus Oral Swabs, a 1.5 fl.oz bottle of Perox-A-Mint solution, and a 0.5 oz tube of Mouth Moisturizer.

The recall was initiated because the oral care solutions were manufactured by a third-party supplier on equipment that was shared with non-pharmaceutical products, creating a risk of 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.

Consumers who have purchased this product should stop using it and contact Sage Products Inc. for a refund or further instructions. The specific lot numbers and expiration dates for the recalled product are listed in the official recall documentation.

The recalled product

Product
Toothette Short Term Oral Swab System with Perox-A-Mint Solution. Contains: 20 Individually wrapped Toothette Plus Oral Swabs with sodium bicarbonate, 1.5 fl.oz/44mL bottle of Perox-A-Mint solution and One (1) 0.5 oz/14g tube of Mouth Moisturizer, Sage Products, Inc., 3909…
Manufacturer
Sage Products Inc
Category
Drug — Oral Care
Hazard
Affected units
966

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: 6002
  • Lots: Product Code: 6002
  • Lots: 52149
  • EXP 08/04/2017
  • 52982
  • EXP 09/21/2017
  • 53942
  • 54042
  • EXP 01/19/2018
  • 54925
  • 54952
  • 54958
  • 54959
  • 54962
  • EXP 03/08/2018
  • 55872
  • EXP 04/25/2018
  • 57449
  • EXP 08/25/2018
  • 58381

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 →

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