| Type of Product |
Medicine |
| TGA Recall Reference |
RC-2018-RN-01488-1 |
| Product Name/Description |
DILART valsartan film-coated tablet blister pack; and DILART HCT valsartan and hydrochlorothiazide film-coated tablet blister pack
All Strengths
All Batches
ARTG Numbers: 167426, 167427, 167425, 167421, 187395, 187396, 187402, 187403, 187397, 187400 and 187399 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/11/2018 |
| Responsible Entity |
|
| Reason/Issue |
Authorities in the EU are taking action after an impurity, N-nitrosodiethylamine (NDEA), was found in some batches of valsartan made by Mylan Laboratories Limited in Hyderabad, India.
EDQM has now suspended the manufacturer’s CEP effectively prohibiting the use of its valsartan in EU medicines. In addition, national authorities in the EU have started recalling affected batches of medicines containing Mylan’s valsartan and are conducting further tests to determine the extent of the contamination. NDEA and the related compound N-nitrosodimethylamine (NDMA), which have been seen in ‘sartans’ from other manufacturers, are classified as probable human carcinogens (substances that could cause cancer).
As with previous findings of NDEA and NDMA, there is no immediate risk to patients. It is riskier for patients to suddenly stop taking high blood pressure medication.
Patients should therefore not stop any treatments without consulting their doctor or pharmacist. |
| Recall Action |
Recall |
| Recall Action Instructions |
Pharmacists are requested to:
1. Inspect all relevant stock on hand and return any DILART or DILART HCT to your primary wholesaler;
2. Existing return processes with your primary wholesaler should be used to return stock; and
3. Complete the supplied customer acknowledgement form and return it to Alphapharm Pty Ltd.
Patients are requested to:
1. Continue taking your DILART and DILART HCT as normal because there is no immediate risk to patients. It is riskier for patients to suddenly stop taking high blood pressure medication; and
2. Where possible, return unused packs to the pharmacy where your DILART or DILART HCT was dispensed, in order to obtain a refund and arrange an alternate supply.
Patients should not stop any treatments without consulting their doctor or pharmacist.
Further information is available on the TGA Website:
https://www.tga.gov.au/alert/dilart-and-dilart-hct-valsartan-0
This action has been closed out on 18/09/2019 |
| Contact Information |
1800 274 276 - Alphapharm |