Urgent consumer level recall: high blood pressure tablets
The Therapeutic Goods Administration (TGA) wishes to notify consumers that Apotex Pty Ltd is undertaking an urgent consumer level recall of specified batches of APO-Perindopril 2mg tablets in blister packs of 30 tablets.
This action is being taken because some cartons of APO-Perindopril 2mg tablets may contain 8mg tablets.
Perindopril is a medicine used to treat high blood pressure and heart failure.
A patient taking an 8mg tablet instead of a 2 mg tablet could suffer serious adverse effects such as low blood pressure, dizziness and fainting.
To date no adverse events have been reported to the TGA in relation this product. Visit http://www.tga.gov.au for more information.
TGA reforms
Changes to the way the TGA evaluates new prescription medicines will ensure many medicines become available to patients much sooner, says Medicines Australia chief executive, Dr Brendan Shaw.
The TGA’s Business Process Reforms will reduce by more than a year the time it takes the regulator to evaluate many medicines for quality, safety and efficacy.
Australian patients are the big winners out of these reforms, Dr Shaw said.
The evaluation and registration of new prescription medicines currently takes up to two years. The new process will reduce that time to between nine and 11 months.
The TGA is committed to ensuring timely access to safe, effective and quality medicines for consumers and the new process will significantly improve the quality of submissions and predictability of timelines for registration of prescription medicines in Australia.
