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Consumers and health professionals are advised that Discus Dental Australia, in consultation with the TGA, are undertaking a recall for certain lots of Relief ACP Oral Care gel and product kits that contain this gel.
Relief ACP Oral Care gel is used to relieve tooth sensitivity.
It has been identified that, in five lots of the product, one side of the double-barrel syringe was inadvertently filled with a teeth whitening gel containing hydrogen peroxide gel (6% concentration as dispensed) rather than the intended component (phosphate gel).
If the incorrect gel is used, the patient will not experience the intended desensitisation and may, for limited time, experience increased sensitivity or gum irritation.
The affected products have the following SKU and lots numbers:
| SKU number | Lot number |
|---|---|
| PV1609 | 14127003 |
| PV1620 | 14141018 |
| 881056701531 | 14135016 |
| 881057001531 | 14135007 |
| 881067501531 | 14097075 |
To identify the SKU and lot numbers, check the product label.
Information for consumers
Discus Dental Australia has written to dentists and dental professionals providing further information, including details of the recall process.
As of 31 October 2014, no serious adverse events have been reported as a result of this issue.
If you have Relief ACP Oral Care gel or a product kit that contains this gel, check the SKU and lot numbers on the product label to see if it is affected by this recall.
If it is from an affected lot, do not use it. Return it to the dentist/dental professional who supplied it to you and they will arrange replacement free of charge.
If it is not from an affected lot, you can continue to use it as normal.
If you have any questions or concerns about this issue, talk to your health professional or call Discus Dental Australia on 1800 621 448.
Information for health professionals
Discus Dental Australia has written to dentists and dental professionals providing further information, including details of the recall process.
If you have Relief ACP Oral Care gel or product kits that contain this gel in stock, check the SKU and lot numbers on the product labels to see if they are affected by this recall.
Cease supplying and using any affected products and return them to Discus Dental Australia in accordance with the recall procedures.
Contact patients who may have received Relief ACP Oral Care gel after 4 August 2014 and inform them of this issue.
If you are treating a patient who is concerned about this situation, reassure them that there have been no serious adverse events reported as a result of the issue.
For further information, call Discus Dental Australia on 1800 621 448.
Reporting problems
Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.