The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0369-2018·Announced 2018-02-21

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

Sage Products Inc. is recalling 879 cases of Toothette Oral Care Single Use 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 FDA classified this as a Class II recall, and the source text describes a theoretical risk of cross-contamination without reporting specific illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Sage Products Inc. is recalling 879 cases of the Toothette Oral Care Single Use System with Antiseptic Oral Rinse and Mouth Moisturizer. The product contains two Toothette Plus swabs with sodium bicarbonate, 0.25 fl oz of Antiseptic Oral Rinse, and 0.7 fl oz of Mouth Moisturizer. 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 is identified by Product Code 6113 and specific lot numbers: 57874 (EXP 09/19/2017), 58903 (EXP 11/15/2017), 60045 (EXP 01/08/2018), and 61109 (EXP 01/22/2018). 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 recalled product and contact Sage Products Inc. for further instructions or a refund. The FDA has classified this as a Class II recall, indicating a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Toothette Oral Care Single Use System with Antiseptic Oral Rinse and Mouth Moisturizer. Contains 2 Toothette Plus swabs with sodium bicarbonate, .25 fl oz/7ml Antiseptic Oral Rinse, 0.7 fl oz/2g Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013.…
Manufacturer
Sage Products Inc
Category
Drug — Oral Care
Hazard
Affected units
879

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 (9)

  • Product Code: 6113
  • Lots: 57874
  • EXP 09/19/2017
  • 58903
  • EXP 11/15/2017
  • 60045
  • EXP 01/08/2018
  • 61109
  • EXP 01/22/2018.

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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