Sage Products Recalls Toothette Oral Care Perox-A-Mint Due to Cross-Contamination
Sage Products Inc. is recalling Toothette Oral Care Perox-A-Mint solution because it was manufactured on equipment shared with non-pharmaceutical products, posing a cross-contamination risk.
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, and the source text describes a theoretical cross-contamination risk without reporting any specific illnesses, injuries, or hospitalizations, which aligns with the criteria for a moderate severity score.
Plain-English summary
Sage Products Inc. is recalling 945 cases of Toothette Oral Care Perox-A-Mint solution, an oral debriding agent. The product is an 8 fl oz/237 ml solution with Product Code 6060. The affected lots are 53057 (expiration date 12/7/2017), 57537, 59140, and 60722 (expiration date 5/23/2017).
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 shared equipment usage created a risk of cross-contamination with other products.
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. Consumers should check their inventory for the specific lot numbers and expiration dates listed above and stop using the product if it matches the recalled description.
The recalled product
- Product
- Toothette Oral Care Perox-A- Mint solution, Oral Debriding Agent 8 fl oz/237 ml. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6060 UPC (01)00618029800152
- Manufacturer
- Sage Products Inc
- Category
- Drug — Oral Care
- Hazard
- Affected units
- 945
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 (7)
- Product Code: 6060
- Lots: 53057
- EXP 12/7/2017
- 57537
- 59140
- 60722
- EXP 5/23/2017.
Distribution
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.
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