Sage Products Recalls Toothette Oral Care Suction Swabs Due to Cross-Contamination
Sage Products Inc. is recalling Toothette Oral Care Suction Swabs because they were 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, which typically corresponds to a moderate severity level where the hazard is unlikely to cause serious adverse health consequences. The source text does not report any illnesses or injuries, and the hazard is a theoretical cross-contamination risk.
Plain-English summary
Sage Products Inc. is recalling 42,628 cases of Toothette Oral Care Suction Swabs with Perox-A-Mint solution and Mouth Moisturizer. The product, identified by Product Code 6513, is being recalled due to cross-contamination with other products. The oral care solutions were manufactured by a third-party supplier on equipment that was shared with non-pharmaceutical products.
The affected lots include 51175, 51220, 51570, 51786, 52104, 52550, 52570, 53460, 53922, 54161, 54294, 54395, 54459, 54963, 54992, 55040, 55049, 55060, 55070, 55486, 55617, 56210, 56772, 56777, 57105, 57329, 57507, 58173, 58429, 59037, 59549, 59920, 60566, 60863, 61292, and 61980. These lots have expiration dates ranging from August 2017 to May 2019. The 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 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 FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Toothette Oral Care Suction Swabs with Perox-A-Mint solution and Mouth Moisturizer, Contains 2 Suctino Swabs with sodium bicarbonate, 0.25 fl oz/7ml Perox-A-Mint solution, 0.07 oz/2g Mouth Moisturizer. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6513
- Manufacturer
- Sage Products Inc
- Category
- Drug — Oral Care
- Hazard
- Affected units
- 42,628
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: 6513
- Lots: 51175
- 51220
- EXP 08/01/2017
- 51570
- EXP 08/15/2017
- 51786
- EXP 08/29/2017
- 52104
- EXP 09/19/2017
- 52550
- 52570
- EXP 10/17/2017
- 53460
- EXP 12/12/2017
- 53922
- EXP 1/16/2018
- 54161
- EXP 02/06/2018
- 54294
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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