The Recall Desk
SevereFDA (Drugs)·D-0360-2018·Announced 2018-02-21

Sage Products Recalls Toothette Oral Care Swab System Due to Cross-Contamination

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

What this means for you

Illness, injury, or structural failure has been reported. 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, which corresponds to a Severe severity score under the rubric, particularly given the risk of cross-contamination with non-pharmaceutical products.

Plain-English summary

Sage Products Inc. is recalling the Toothette Oral Care Short-Term Oral Swab System with Perox-A-Mint solution. The product includes 20 Toothette Plus Oral Swabs with sodium bicarbonate, a 1.5 fl.oz/44ml bottle of Perox-A-Mint solution, and a .5 oz/14g tube of Mouth Moisturizer. The recall affects 25,409 cases distributed nationwide in the USA and Puerto Rico, as well as in Canada, the United Kingdom, Ireland, the Netherlands, and New Zealand.

The recall was initiated because the oral care solutions were manufactured by a third-party supplier on equipment that was shared with non-pharmaceutical products. This shared equipment usage created a risk of cross-contamination with other products. The agency has classified this recall as Class II.

Consumers who have purchased this product should stop using it and contact Sage Products Inc. for further instructions or a refund. The affected lots have expiration dates ranging from August 2017 to January 2019.

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, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013.
Manufacturer
Sage Products Inc
Category
Drug — Oral Care
Hazard
Affected units
25,409

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)

  • Lots:52115
  • EXP 08/04/2017
  • 52284
  • 52631
  • 53005
  • EXP 09/21/2017
  • 53012
  • 53343
  • EXP 12/02/2017
  • 53475
  • 53754
  • EXP 12/06/2017
  • 53765
  • 54130
  • 54146
  • 54158
  • 54166
  • 54179
  • 54502
  • EXP 01/19/2018

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 →

Related recalls

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Same hazard · cross contamination

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