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

PRA number

2017/16424

Published date

Product description

Apo-Perindopril Arginine is a medicine used to treat high blood pressure, heart failure or coronary artery disease.

15 batches of APO-Perindopril Arginine are affected:

APO-Perindopril Arginine 2.5mg
Batch/Lot Number: (L)NC6619 Expiry: 02/2020
Batch/Lot Number: (L)NC6620 Expiry: 02/2020
Batch/Lot Number: (L)MX1699 Expiry: 05/2019
Batch/Lot Number: (L)MX1697 Expiry: 05/2019
Batch/Lot Number: (L)MX1698 Expiry: 05/2019
AUST R: 184808

APO-Perindopril Arginine 5mg
Batch/Lot Number: (L)NC6671 Expiry: 03/2020
Batch/Lot Number: (L)NC6670 Expiry: 03/2020
Batch/Lot Number: (L)MX1702 Expiry: 05/2019
Batch/Lot Number: (L)NC6672 Expiry: 03/2020
Batch/Lot Number: (L)MX1700 Expiry: 05/2019
Batch/Lot Number: (L)MX1701 Expiry: 05/2019
AUST R: 184806

APO-Perindopril Arginine 10mg
Batch/Lot Number: (L)MX1705 Expiry: 05/2019
Batch/Lot Number: (L)MX1703 Expiry: 05/2019
Batch/Lot Number: (L)MX1704 Expiry: 05/2019
Batch/Lot Number: (L)NC6729 Expiry: 03/2020
AUST R: 184812
apo perindopril argines tablets
Identifying features

Other identifying numbers

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

Reasons the product is recalled

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.

The hazards to consumers

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

What consumers should 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

Nationally

Responsible regulator

Therapeutic Goods Administration is the responsible regulator for this recall.

Product category

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