The Recall Desk
ModerateFDA (Drugs)·D-0391-2018·Announced 2018-02-21

Sage Products Recalls Toothette Oral Care Suction Toothbrush

Sage Products is recalling Toothette Oral Care Suction Toothbrush kits due to cross-contamination with non-pharmaceutical products during manufacturing.

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 does not report any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Sage Products, Inc. is recalling 4,255 cases of Toothette Oral Care Suction Toothbrush with Perox-A-Mint solution. The product contains a suction toothbrush with sodium bicarbonate, Perox-A-Mint solution, mouth moisturizer, and an applicator swab. The recall involves specific product lots with expiration dates ranging from August 2017 to March 2019.

The recall was initiated because the oral care solutions were manufactured by a third-party supplier on equipment shared with non-pharmaceutical products, resulting in cross-contamination. The affected units were distributed nationwide in the USA and Puerto Rico, as well as in Canada, the United Kingdom, Ireland, the Netherlands, and New Zealand.

Consumers should stop using the recalled products and contact Sage Products, Inc. for a refund or replacement. The company is located at 3909 Three Oaks Road, Cary, IL 60013.

The recalled product

Product
Toothette Oral Care Suction Toothbrush with Perox-A-Mint solution. Contains 1 Suction Toothbrush with sodium bicarbonate, 0.25 fl oz/ 7ml Perox-A-Mint solution, 0.07 oz/2g Mouth Moisturizer, 1 Applicator Swab. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Cod
Manufacturer
Sage Products Inc
Category
Drug — Oral Care
Hazard
Affected units
4,255

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: 6671
  • Lots: 51716
  • EXP 08/22/2017
  • 52904
  • EXP 11/07/2017
  • 53686
  • EXP 01/03/2018
  • 54601
  • 54617
  • EXP 03/06/2018
  • 55377
  • EXP 04/24/2018
  • 56658
  • 07/17/2018
  • 57927
  • EXP 09/25/2018
  • 58936
  • EXP 11/06/2018
  • 59805
  • EXP 01/08/2019

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 →

Related recalls

Same manufacturer · Sage Products Inc

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Same hazard · cross contamination

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