The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0291-2019·Announced 2018-12-19

CAO Group Recalls SHEER DesenZ Desensitizing Treatment Due to cGMP Violations

CAO Group, Inc. is recalling SHEER DesenZ Desensitizing Treatment because cGMP violations were noted during the firm's most recent inspection.

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 indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source text cites cGMP violations without reporting specific injuries or illnesses, aligning with a Moderate severity rating.

Plain-English summary

CAO Group, Inc. is recalling SHEER DesenZ Desensitizing Treatment, a prescription-only product containing Potassium Nitrate 12mg per film. The recall involves 71 cartons of the product, which were distributed nationwide in the US.

The recall was initiated because current Good Manufacturing Practice (cGMP) violations were noted during the firm's most recent inspection. The affected lots are # 170626 (expiration date 6/26/2019) and # 180131 (expiration date 01/31/2020).

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
SHEER DesenZ Desensitizing Treatment, Rx Only, Potassium Nitrate 12mg per film. CAO GROUP, INC, 4628 West Skyhawk Drive West Jordan, UT 84084. UPC: 8 72320 00072 1 NDC 1406000304
Manufacturer
CAO Group, Inc.
Category
Drug — Dental / Oral Care
Hazard
Affected units
71

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 (4)

  • Lot # 170626
  • EXP 6/26/2019
  • and 180131
  • EXP 01/31/2020

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by CAO Group, 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 4 products in this recall →

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