International safety notice
It has been confirmed that some of the products in question had gel liquefaction. The cause was corrosion of some of the production equipment at a subcontractor manufacturing intermediate products, which resulted in components (copper ions) getting mixed into the gel. Here are some things I did. Although there is a very low risk that the product will be affected by We will carry out a voluntary recall of the lots that may have been contaminated.
Japan / PMDA Recalls · JPN · Apr 4, 2023
Key facts
| Title | It has been confirmed that some of the products in question had gel liquefaction. The cause was corrosion of some of the production equipment at a subcontractor manufacturing intermediate products, which resulted in components (copper ions) getting mixed into the gel. Here are some things I did. Although there is a very low risk that the product will be affected by We will carry out a voluntary recall of the lots that may have been contaminated. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Pharmaceutical-containing dental tooth surface cleaning aid Sales name: White Essence Whitening Home 10% |
| Manufacturer | White Essence Co., Ltd. |
| Models | 220301-06, 220134-01, 220136-01, 220131-02, 220136-02, 220135-01, 220301-02, 220301-05, 211103-01, 220134-02, 220301-01, 220131-01 |
| Date | Apr 4, 2023 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1