HPS Pharmacies wish to advise that Pfizer, in consultation with the Therapeutic Goods Administration (TGA), has initiated a drug recall for Champix® as follows:
Varenicline tartrate 1mg
This recall has been initiated following the identification of a nitrosamine impurity, N-nitrosovarenicline, above Pfizer’s acceptable concentration limit. Nitrosamines are commonly found in low levels in a variety of foods and some drinking water. However, long-term exposure can increase the risk of cancer.
The two lots affected by this recall action are: EM9960 and EM9961.
As a precautionary measure, Pfizer is also pausing distribution of Champix® pending the results of further testing. Alternative treatment options may need to be considered.
Please inspect your stock and quarantine all affected products. If HPS Pharmacies provide imprest management services to your facility, an HPS representative will inspect all stock stored in the designated imprest areas at the earliest opportunity. All affected products will be quarantined for return to the supplier and HPS Pharmacies will arrange for replacement stock as soon as possible. An HPS Pharmacies staff member will contact senior medical and nursing staff if there is an immediate impact to your facility.
Retain this notice in a prominent position, including in other related business units for one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.
Should you require further information regarding this matter, please contact Pfizer on 1800 629 921 or your pharmacist at HPS Pharmacies.