The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0359-2018·Announced 2018-02-21

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

Sage Products Inc. is recalling 835 cases of Toothette Oral Care Short Term Oral Swab Systems because they 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, and the source text describes a theoretical risk of cross-contamination without reporting any specific illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Sage Products Inc. is recalling 835 cases of the Toothette Oral Care Short Term Oral Swab System with Perox-A-Mint solution. The product includes 20 Toothette Plus Oral Swabs, a bottle of Perox-A-Mint solution, a tube of Mouth Moisturizer, a tube of Sodium Bicarbonate Mouthpaste, and an Ultra-Soft Toothbrush. The affected product code is 6001-D, with NDC 53462-024-30.

The recall was initiated because the oral care solutions were manufactured by a third-party supplier on equipment shared with non-pharmaceutical products, creating a risk of cross-contamination. The affected lots include 52414, 53322, 53336, 53673, 54438, 54932, 55506, and 2015323-01, with expiration dates ranging from September 21, 2017, to April 25, 2018.

The 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 stop using the product and contact the manufacturer for instructions on disposal or return.

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…
Manufacturer
Sage Products Inc
Category
Drug — Oral Care
Hazard
Affected units
835

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 (15)

  • Product Code: 6001-D
  • Lots: 52414
  • 53322
  • EXP 09/21/2017
  • 53336
  • EXP 12/02/2017
  • 53673
  • EXP 12/06/2017
  • 54438
  • EXP 01/19/2018
  • 54932
  • EXP 03/08/2018
  • 55506
  • EXP 04/25/2018
  • 2015323-01

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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