HPS Pharmacies wish to advise that Apotex, in consultation with the Therapeutic Goods Administration (TGA), have given notice of a drug recall for all strengths and all batches of APO-Valsartan as follows:
Valsartan 40mg, 80mg, 160mg, and 320mg Tablets
ARTG 185806, 185814, 185821, and 185826
This drug recall has been initiated following identification of trace amounts of the impurity, N-nitrosodiisopropylamine (NDIPA), in these products. NDIPA belongs to the N-nitroso chemical class which contains mutagenic and carcinogenic compounds. Recall of APO-Valsartan products is, therefore, being undertaken as a precautionary measure.
Please inspect your stock and quarantine all APO-Valsartan 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 your pharmacist at HPS Pharmacies, or Apotex on 1800 133 300.