Detection of trace element impurity leads to a recall of Apotex’s Valsartan product range
Apotex Pty Ltd, in consultation with the TGA, has issued a recalling of all batches and strengths of the company’s supplied APO-Valsartan tablet blister packs.
The recall has been prompted due to the presence of trace elements of an impurity, the company says.
The products being recalled are:
- APO-Valsartan 40 mg tablets (AUST R 185806)
- APO-Valsartan 80 mg tablets (AUST R 185814)
- APO-Valsartan 160 mg tablets (AUST R 185821)
- APO-Valsartan 320mg tablets (AUST R 185826)
“As a precautionary measure, APO-Valsartan is being recalled due to the N Nitrosodiisopropylamine (NDIPA) impurity in the finished products,” Apotex said in a media release.
“NDIPA belongs to the N-nitroso chemical class known to contain mutagens and carcinogens.
“Based on information available to Apotex to date, the company expects the health risk posed by the use of APO-Valsartan tablets to be very low”.
Pharmacists are advised to offer patients returning affected packs of APO-Valsartan a full refund, and an alternative equivalent product by their pharmacist. Alternatively, they can be referred to their doctor immediately, Apotex says.
“We sincerely regret any inconvenience caused by this incident to both our customers and
consumers, and thank all parties for their understanding, patience and support of Apotex’s ongoing
commitment to ensuring public health and safety,” said Roger Millichamp, Apotex Managing Director, Asia Pacific.
For questions pertaining to the APO-Valsartan product recall, contact Apotex Customer
Service on 1800 276 839 to coordinate a refund.