APOTEX has announced the recall of four strengths of its APO-Valsartan tablet blister packs, due to the presence of trace elements of N-Nitrosodiisopropylamine (NDIPA) in the finished products.
NDIPA belongs to the N-nitroso chemical class known to contain mutagens and carcinogens, with the recall being conducted in consultation with the Therapeutic Goods Administration.
The products being recalled include APO-Valsartan tablets in the 40mg, 80mg, 160mg and 320mg strengths, with Apotex saying patients returning affected packs of the product should be given a full refund and offered an alternative equivalent product by the pharmacist, or referred to their doctor immediately.
Apotex said based on information available it expects the health risk posed by the use of APO-Valsartan tablets to be very low.
The Apotex recall follows a similar action undertaken by Alphapharm trading as Mylan Australia, which initiated a nationwide consumer-level recall of all batches of its Dilart and Dilart HCT valsartan medicines in Australia last month (PD 26 Nov) due to potential contamination with NDEA (N-nitorsodiethylamine).
Manufacturing issues have affected a range of valsartan products across the globe this year, impacting products containing ingredients from a number of Chinese and Indian manufacturers.
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