Apotex Pty Ltd — Apo-Perindopril Arginine 2.5 mg, 5 mg and 10 mg tablets (bottle) - extended recall (new batches)

apo perindopril argines tablets

Identifying features

See batch/lot numbers and expiry dates in Product Description above

What are the defects?

It has been identified that some bottles from these batches may be contaminated with dark particles of silica, presumably released from the desiccant cylinder that is placed inside the bottle to keep the contents dry and protected from moisture. The particles may be large enough to see as specks or appear as a dust that discolours the tablets themselves and/or the inside of the bottle.

What are the hazards?

This potential contamination is classified as a quality defect and is not considered to impact product safety or efficacy.

What should consumers do?

If you or someone you provide care for takes Apo-Perindopril Arginine 2.5 mg, 5 mg or 10 mg tablets, check the batch number on the bottle to see if it is from an affected batch. If you have a bottle from an affected batch, return it to a pharmacy for a refund or replacement.

Please note that this potential contamination is classified as a quality defect rather than a safety-related issue. You are unlikely to experience any health problems as a result of this issue.

If you have any other questions or concerns about this issue, talk to your health professional.

Where the product was sold

Responsible regulator

Therapeutic Goods Administration is the responsible regulator for this recall.

Product category