The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0390-2018·Announced 2018-02-21

Sage Products Recalls Toothette Oral Care Suction Swabs Due to Cross-Contamination

Sage Products Inc. is recalling Toothette Oral Care Suction Swabs 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, which typically involves a situation that may cause temporary or medically reversible adverse health consequences. The hazard is cross-contamination with non-pharmaceutical products, which is a significant quality issue but does not meet the criteria for Class I (death/serious injury) or Class III (unlikely to cause adverse health consequences).

Plain-English summary

Sage Products Inc. is recalling 4,650 cases of Toothette Oral Care Suction Swabs with Perox-A-Mint solution. The product contains suction swabs with sodium bicarbonate, Perox-A-Mint solution, mouth moisturizer, and an applicator swab.

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, resulting in cross-contamination. The affected lots have expiration dates ranging from August 2017 to November 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 return it to the place of purchase or contact the manufacturer for a refund.

The recalled product

Product
Toothette Oral Care Suction Swabs with Perox-A-Mint solution. Contains 2 Suction Swabs with sodium bicarbonate, 0.25 fl oz/ 7ml Perox-A-Mint solution, 0.07 oz/2g Mouth Moisturizer, 1 Applicator Swab. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6613
Manufacturer
Sage Products Inc
Category
Drug — Oral Care
Hazard
Affected units
4,650

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 (17)

  • Product Code: 6613
  • Lots: 51330
  • EXP 08/08/2017
  • 52400
  • EXP 10/03/2017
  • 53198
  • EXP 11/28/2017
  • 54582
  • EXP 02/27/2018
  • 55837
  • EXP 05/22/2018
  • 57007
  • EXP 08/07/2018
  • 57904
  • EXP 09/25/2018
  • 58931
  • EXP 11/06/2018.

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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