The Recall Desk
SevereFDA (Drugs)·D-0362-2018·Announced 2018-02-21

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.

What this means for you

Illness, injury, or structural failure has been reported. 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 821
Manufacturer
Sage Products Inc
Category
Drug — Oral Care
Hazard
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

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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