The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0365-2018·Announced 2018-02-21

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

Sage Products Inc. is recalling Toothette Oral Care Single Use Systems because they were manufactured on equipment shared with non-pharmaceutical products, posing a cross-contamination risk.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for significant injury or property damage, or those involving structural defects or significant contamination risks, are rated as Severe (4).

Plain-English summary

Sage Products Inc. is recalling 15,644 cases of Toothette Oral Care Single Use Systems. The product includes Toothette Plus Swabs, Perox-A-Mint solution, and 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 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 notice, ranging from August 2017 to April 2019.

Consumers should stop using the affected products and contact Sage Products Inc. for further instructions or a refund. The recall is classified as FDA Class II, 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 Single Use System with Perox-A-Mint solution and Mouth Moisturizer. Contains 2 Toothette Plus Swabs with sodium bicarbonate, .25 fl oz/7ml Perox-A-Mint solution and .07 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
15,644

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: 6013
  • Lots: 51361
  • EXP 8/8/2017
  • 51834
  • EXP 9/6/2017
  • 52473
  • EXP 10/17/2017
  • 53225
  • EXP 11/28/2017
  • 54102
  • EXP 1/30/2018
  • 54754
  • EXP 3/13/2018
  • 55222
  • 55264
  • EXP 4/10/2018
  • 56683
  • EXP 7/17/2018
  • 57262
  • EXP 8/21/2018

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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