The Recall Desk
ModerateFDA (Drugs)·D-0384-2018·Announced 2018-02-21

Sage Products Recalls Toothette Oral Care Suction Toothbrush Due to Cross Contamination

Sage Products Inc. is recalling Toothette Oral Care Suction Toothbrush kits 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 corresponds to a moderate severity score when no specific injuries or illnesses are reported in the source text.

Plain-English summary

Sage Products Inc. is recalling 10,505 cases of Toothette Oral Care Suction Toothbrush with Perox-A-Mint solution and Mouth Moisturizer. The product contains a suction toothbrush with sodium bicarbonate, Perox-A-Mint solution, Mouth Moisturizer, and an applicator swab. The recall is due to cross-contamination with other products, as the oral care solutions were manufactured by a third-party supplier on equipment shared with non-pharmaceutical products.

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, ranging from October 2017 to April 2019.

Consumers should stop using the product and contact Sage Products Inc. for further instructions or a refund. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Toothette Oral Care Suction Toothbrush with Perox-A-Mint solution and Mouth Moisturizer. 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,
Manufacturer
Sage Products Inc
Category
Drug — Oral Care
Hazard
Affected units
10,505

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: 6572
  • Lots: 52349
  • 52367
  • 52370
  • 52438
  • EXP 10/03/2017
  • 52457
  • 52471
  • EXP 10/17/2017
  • 53106
  • EXP 11/14/2017
  • 53569
  • EXP 12/19/2017
  • 53945
  • EXP 01/30/2018
  • 54354
  • EXP 02/20/2018
  • 54950
  • EXP 03/28/2018
  • 55452

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 →