APOTEX has written to pharmacists across the country to provide details of recall procedures for contaminated batches of Apo-Perindropil Arginine 2.5mg, 5mg and 10mg tablets.
According to the TGA, it has been identified that some bottles from batches NC6619 exp 02/2020 (2.5mg), NC6671 exp 03/2020 (5mg) and MX1705 exp 05/2019 (10mg) may be contaminated with dark particles of silica.
It's presumed the particles have been released from the dessicant cylinder that is placed inside the bottle to ensure the contents are kept dry.
The particles may be large enough to see as small specks, or simply appear as a dust that discolours the tablets and/or the inside of the bottle.
The potential contamination is classified as a quality defect and is not considered to impact product safety or efficacy.
Consumers are being advised to check the batch number and if it is from an affected batch, return it to a pharmacy for a refund or replacement.
Health problems are unlikely to be experienced as a result of the issue, the TGA said - more information at www.tga.gov.au.
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