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Recall Announcement: Fatuite Perfect Proof UV Defense

IAC, the manufacturer and distributor of the Fatuite Perfect Proof UV Defense, has issued a voluntary recall due to the risk of crystal formation in products over time. Following discussions with FATUITE Co., Ltd., it was determined that all sold products, including sample pouches, will be recalled. We sincerely apologize for the concern and inconvenience this may cause to our customers and associates.

Product Details

• - Product Name: Fatuite Perfect Proof UV Defense
• - Affected Lot: All sold products and sample pouches

Cause and Background

Direct Cause

The issue arises from an improper blend of two raw materials. The manufacturer failed to account for the inspection results of the prototype and the feedback from FATUITE Co., Ltd., leading to the production being made with a different formulation than what was approved. Additionally, they neglected essential tests after manufacturing, resulting in the release of incorrect products. The lack of collaboration within the development department at the manufacturer is a key factor in this issue.

Background

Initially, the product was to be developed using 'Formula A.' However, the manufacturer later proposed an improved 'Formula AB.' This new formula showed signs of crystallization in stability tests, prompting both parties to revert to the original 'Formula A' for production.

Unfortunately, due to internal communication errors within the manufacturer’s development department, the risk of crystallization from 'Formula AB' was communicated as if it were the approved formula.
Before production, FATUITE Co., Ltd. requested confirmation that 'Formula A' was indeed the formula being used. The manufacturer, without verifying the details, incorrectly asserted that they were producing a product without crystallization.

Furthermore, the manufacturer failed to conduct a stability test soon after bulk production. This omission led to the undetected risk of crystallization until the problem was identified in a test conducted about a month later on the filled products.

All these issues stem from a lack of proper internal communication and record management within the manufacturer, highlighting deficiencies in their internal controls. FATUITE Co., Ltd. was left to make decisions based on our report, regarding events that occurred outside their management capacity.

Usage Considerations

Currently, there have been no reported health issues from using the product before crystallization begins. However, once crystallization occurs, the crystals may irritate the skin upon contact. We urge customers in possession of the affected products to refrain from using them, regardless of whether crystallization is apparent, and to cooperate with the return process.

Future Measures

Going forward, we are committed to strengthening management of prototype quality verification results within our development department. This includes checking ingredient mixing ratios prior to manufacturing, confirming production records, and enhancing the information sharing system among development staff to prevent similar incidents from happening again.

We deeply apologize once again for any inconvenience and concern this issue has caused to our customers, FATUITE Co., Ltd., and all stakeholders involved.

IAC Co., Ltd.
President: Naohisa Okumura
Website: https://www.cosmetics-iac.jp/