The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0350-2018·Announced 2018-02-21

Sage Products Recalls Toothette Oral Care Perox-A-Mint Solution

Sage Products is recalling Toothette Oral Care Perox-A-Mint Solution packets due to cross-contamination with non-pharmaceutical products during manufacturing.

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 FDA classified this as a Class II recall. The source text does not report any illnesses or injuries, and the hazard is described as cross-contamination with non-pharmaceutical products, which fits the criteria for a moderate severity rating involving low-risk contamination or precautionary measures.

Plain-English summary

Sage Products, Inc. is recalling 7,490 packets of Toothette Oral Care Perox-A-Mint Solution, an oral debriding agent. The product is packaged in 1.5 fl. oz./44 mL packets. The recall is being conducted 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 product was distributed nationwide in the USA and Puerto Rico, as well as in Canada, the United Kingdom, Ireland, the Netherlands, and New Zealand. The recall includes specific lots with expiration dates ranging from November 2017 to February 2019. Consumers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice.

Consumers who have purchased this product should stop using it and contact Sage Products, Inc. for a refund or further instructions. 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 Perox-A-Mint Solution, Oral Debriding Agent, 1.5 fl. oz./44 mL. packet. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6065. UPC 6 18029 80018 3
Manufacturer
Sage Products Inc
Category
Drug — Oral Care
Hazard
Affected units
7,490

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: 6065
  • Lots: 51450
  • EXP 9/19/2017
  • 52551
  • EXP 11/30/2017
  • 53180
  • EXP 1/16/2018
  • 54074
  • EXP3/11/2018
  • 54855
  • EXP 4/28/2018
  • 010437
  • EXP1/12/2019
  • 020637
  • EXP 2/14/2019
  • 51256
  • EXP 5/27/2018
  • 081066
  • EXP 8/25/2018
  • 090246

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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