Sage Products Recalls Corinz Oral Care Kits Due to Cross-Contamination
Sage Products is recalling 94 cases of Independent Care System Corinz oral care 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 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 agency classified this as a Class II recall involving cross-contamination with non-pharmaceutical products, which meets the rubric criteria for a Severe rating due to the potential for significant harm from foreign substance exposure.
Plain-English summary
Sage Products, Inc. is recalling 94 cases of the Independent Care System Corinz oral care kit. The product includes a 1.5 fl oz bottle of Corinz Mouthwash, a 0.5 oz tube of Mouth Moisturizer, a 0.3 oz tube of Sodium Bicarbonate Mouthpast, and one Ultra-Soft toothbrush. The affected product is identified by Product Code 6004, Lot 61610, and an expiration date of 11/17/2018.
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, creating a risk of cross-contamination. The agency has classified this as a Class II recall.
The affected units 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 product and contact the recalling firm for instructions on how to return or dispose of the items.
The recalled product
- Product
- Independent Care System Corinz, Contains: 1.5 fl oz bottle Corinz Mouthwash, 0.5 oz/14g tube of Mouth Moisturizer, 0.3 oz/9g tube of Sodium Bicarbonate Mouthpast, 1 Ultra-Soft toothbrush. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6004 UPC 6 18029…
- Manufacturer
- Sage Products Inc
- Category
- Drug — Oral Care
- Affected units
- 94
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 (3)
- Product Code: 6004
- Lots: 61610
- EXP 11/17/2018
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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