The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0353-2018·Announced 2018-02-21

Sage Products Recalls Toothette Suction Toothbrush Due to Cross-Contamination

Sage Products Inc. is recalling Toothette Suction Toothbrush kits because oral care solutions 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 FDA classified this recall as Class II. According to the severity rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving potential health consequences from contamination, even if specific hospitalization reports are not detailed in the provided text snippet.

Plain-English summary

Sage Products Inc. is recalling 38,792 cases of Toothette Suction Toothbrush with Perox-A-Mint solution and Mouth Moisturizer. The recall involves Product Code 6512 and multiple lot numbers with expiration dates ranging from August 2017 to April 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, resulting in cross-contamination. 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 stop using the recalled products and contact Sage Products Inc. for further instructions or a refund. The FDA has classified this recall as Class II, indicating that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
Toothette Suction Toothbrush with Perox-A-Mint solution and Mouth Moisturizer. Includes 0.25 fl.oz./7mL Perox-A-Mint solution, 0.07oz/2g Mouth Moisturizer. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. NDC: 53462-922-16
Manufacturer
Sage Products Inc
Category
Drug — Oral Care
Hazard
Affected units
38,792

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: 6512
  • Lots: 51381
  • EXP 8/8/2017
  • 51433
  • 51453
  • EXP 8/15/2017
  • 51931
  • EXP 9/12/17
  • 52754 EXP 10/31/2017
  • 53326
  • EXP 11/28/2017
  • 53826
  • EXP 1/9/2018
  • 54266
  • EXP /15/2018
  • 54606
  • EXP 3/6/2018
  • 54872
  • EXP 3/21/2018
  • 55310

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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