| Type of Product |
Medicine |
| TGA Recall Reference |
RC-2016-RN-00880-1 |
| Product Name/Description |
Chlorofluor Gel 30mL and 250mL bottles and 100mL pump pack
(aids in the treatment of gingivitis, dental plaque and helps reduce discomfort and duration of mouth ulcers)
Batch Number: BK119 (All bottle sizes)
Expiry Date: October 2017
AUST R Number: 21505 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
1/07/2016 |
| Responsible Entity |
|
| Reason/Issue |
Professional Dentist Supplies Pty Ltd is recalling batch BK119 of Chlorofluor Gel due to bacterial contamination. The contamination was identified following a cluster of cases of colonisation or infection in intensive care patients at a single hospital. Investigations are ongoing but have included testing of unopened bottles of Chlorofluor Gel from the same batch that was used in the treatment of the affected patients. This testing detected high levels of Burkholderia cepacia (B. cepacia).
B. cepacia poses little medical risk to healthy people. However, people with weakened immune systems, such as intensive care patients, may be more susceptible to B. cepacia infections and at increased risk of associated health problems. |
| Recall Action |
Recall |
| Recall Action Instructions |
Consumers are advised that if they have Chlorofluor Gel (all bottle sizes) from batch number BK 119, stop using it. Return it to the place of purchase for a refund or call Professional Dentist Supplies' customer service line on (03) 9761 6615 to arrange for the return of affected product and getting a refund. Retailers and other distributors are advised to quarantine all units from the affected batch and inform PDS so that they can arrange for the stock to be recovered and a credit note be issued. For more details, please see https://www.tga.gov.au/alert/chlorofluor-gel . This action has been closed-out on 03/03/2017. |
| Contact Information |
03 9761 6615 - PDS Customer Service |