The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0364-2018·Announced 2018-02-21

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

Sage Products is recalling 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 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, 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 14,753 cases of Toothette Oral Care Single Use System With Perox-A-Mint solution. The product contains two Toothette Plus swabs with sodium bicarbonate and a 0.25 fl oz/7ml tube of Perox-A-Mint solution. The recall involves specific lot numbers with expiration dates ranging from August 2017 to June 2019.

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 cross-contamination risk prompted the FDA to classify the recall as Class II.

The affected products were distributed nationwide in the USA and Puerto Rico, as well as in Canada, the United Kingdom, Ireland, the Netherlands, and New Zealand. Consumers should check their products for the specific lot numbers listed in the recall notice and stop using them if they match.

The recalled product

Product
Toothette Oral Care Single Use System With Perox-A-Mint solution. Contains: 2 Toothette Plus swabs with sodium bicarbonate, .25 fl oz/7ml tube of Perox-A-Mint solution. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6012 UPC (01)00618029800077
Manufacturer
Sage Products Inc
Category
Drug — Oral Care
Hazard
Affected units
14,753

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: 6012
  • Lots: 51502
  • EXP 08/15/2017
  • 51883
  • 09/06/2017
  • 53585
  • EXP12/19/2018
  • 54222
  • 54226
  • EXP 02/06/2018
  • 54811
  • EXP 03/21/2018
  • 55574
  • EXP 05/08/2018
  • 56190
  • EXP 06/12/2018
  • 56346
  • EXP 06/26/2018
  • 56616
  • EXP 07/12/2018

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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