The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0361-2018·Announced 2018-02-21

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

Sage Products Inc. is recalling the Toothette Oral Care Short Term Oral Care System because it was 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 may cause temporary or medically reversible health consequences. The hazard is a theoretical cross-contamination risk with non-pharmaceutical products, and no specific illnesses or injuries are reported in the source text.

Plain-English summary

Sage Products Inc. is recalling the Toothette Oral Care Short Term Oral Care System with Perox-A-Mint solution. The recall involves 849 cases of the product, which includes a bottle of Perox-A-Mint solution, a tube of Mouth Moisturizer, a tube of Sodium Bicarbonate Mouthpaste, and an Ultra-Soft Toothbrush.

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. This cross-contamination risk affects the safety of the pharmaceutical product.

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 should check their inventory for the specific lot numbers and expiration dates listed in the recall notice and stop using the product if it matches the recalled items.

The recalled product

Product
Toothette Oral Care Short Term Oral Care System with Perox-A-Mint solution, Contains 1.5 fl oz/44 ml bottle of Perox-A-Mint solution, 0.5 oz/14g tube of Mouth Moisturizer, 0.3 oz/9g tube of Sodium Bicarbonate Mouthpaste, 1 Ultra-Soft Toothbrush, Sage Products, Inc., 3909 Three…
Manufacturer
Sage Products Inc
Category
Drug — Oral Care
Hazard
Affected units
849

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 (10)

  • Product Code: 6002-D
  • Lots: 57942
  • EXP 09/08/2018
  • 58186
  • 58673
  • EXP 09/14/2018
  • 60297
  • EXP 12/19/2018
  • 61893
  • EXP 02/14/2019.

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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