The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0363-2018·Announced 2018-02-21

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

Sage Products Inc. is recalling Toothette Oral Care Daily Oral Cleansing Kits 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 indicates a situation where use of the product could cause temporary or medically reversible health consequences. The source text describes a cross-contamination issue but does not report specific illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Sage Products Inc. is voluntarily recalling 637 cases of the Toothette Oral Care Daily Oral Cleansing Kit, Petite Size, with Antiseptic Oral Rinse. The product includes 10 individually wrapped oral swabs, 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 is identified by Product Code 6006 and UPC (01)00618029800053. Specific lot numbers and expiration dates include: Lots 54523, 54629, and 55528 (EXP 02/06/2018); Lots 56864 and 57915 (EXP 04/12/2018); Lots 58884, 60137, and 61047 (EXP 05/23/2018); and Lot 61123 (EXP 02/10/2019). 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 check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled description, consumers should stop using it and contact Sage Products Inc. for further instructions or a refund.

The recalled product

Product
Toothette Oral Care Daily Oral Cleansing Kit Petite Size with Antiseptic Oral Rinse. Contains: 10 Petite Size Oral Swabs, individually wrapped, 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…
Manufacturer
Sage Products Inc
Category
Drug — Oral Care
Hazard
Affected units
637

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 (14)

  • Product Code: 6006
  • Lots: 54523
  • 54629
  • 55528
  • EXP 02/06/2018
  • 56864
  • 57915
  • EXP 04/12/2018
  • 58884
  • 60137
  • 61047
  • EXP 05/23/2018
  • 61123
  • EXP 02/10/2019

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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