The Recall Desk
ModerateFDA (Drugs)·D-0367-2018·Announced 2018-02-21

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

Sage Products Inc. is recalling 2,548 cases of Toothette Oral Care Short Term Oral Swab Systems because they 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, and the source text describes a voluntary precautionary recall due to cross-contamination on shared equipment without reporting specific illnesses or injuries, aligning with the Moderate severity criteria.

Plain-English summary

Sage Products Inc. is voluntarily recalling 2,548 cases of the Toothette Oral Care Short Term Oral Swab System with Antiseptic Oral Rinse. The product contains 20 Toothette Plus Oral Swabs with sodium bicarbonate, a 1.5 fl oz bottle of Antiseptic Oral Rinse, and a 0.5 oz tube 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 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, including lots 57856, 58296, 58814, 54496, 55225, 56214, 56280, 57109, 58288, 59175, 59487, 60187, 58815, 59157, 61262, and 61740.

Consumers who have purchased this product should stop using it and contact Sage Products Inc. for instructions on how to return the product or obtain a refund. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Toothette Oral Care Short Term Oral Swab System with Antiseptic Oral Rinse, Contains 20 Toothette Plus Oral Swabs with sodium bicarbonate, 1.5 fl oz/44ml bottle of Antiseptic Oral Rinse, .5 oz.14g tube of Mouth Moisturizer. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 6001
Manufacturer
Sage Products Inc
Category
Drug — Oral Care
Hazard
Affected units
2,548

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: 6100
  • Lots: 57856
  • 58296
  • 58814
  • EXP 11/24/2017
  • 54496
  • 55225
  • 56214
  • EXP 02/06/2018
  • 56280
  • 57109
  • 58288
  • EXP 04/12/2018
  • 59175
  • 59487
  • 60187
  • EXP 05/23/2018
  • 58815
  • 59157
  • EXP 05/24/2018

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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Same hazard · cross contamination

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