Apo-Perindopril Arginine

Update 2 – additional batches being recalled

27 November 2017

Consumers and health professionals are advised that Apotex, in consultation with the TGA, is recalling four additional batches of Apo-Perindopril Arginine.

The full list of affected products and batch numbers are:

Apo-Perindopril Arginine tablet package.

Apo-Perindopril Arginine 2.5 mg:

  • NC6619 EXP 02/2020
  • NC6620 EXP 02/2020
  • MX1699 EXP 05/2019
  • MX1697 EXP 05/2019
  • MX1698 EXP: 05/2019

Apo-Perindopril Arginine 5 mg:

  • NC6671 EXP 03/2020
  • NC6670 EXP 03/2020
  • MX1702 EXP 05/2019
  • NC6672 EXP 03/2020
  • MX1700 EXP: 05/2019
  • MX1701 EXP: 05/2019

Apo-Perindopril Arginine 10 mg:

  • MX1705 EXP 05/2019
  • MX1703 EXP 05/2019
  • MX1704 EXP 05/2019
  • NC6729 EXP: 03/2020

All other information and advice provided in the below statements, published 9 November 2017, remains accurate and appropriate.

Update – additional batches being recalled

17 November 2017

Consumers and health professionals are advised that Apotex, in consultation with the TGA, is recalling eight additional batches of Apo-Perindopril Arginine.

The full list of affected products and batch numbers are:

Apo-Perindopril Arginine 2.5 mg:

  • NC6619 EXP 02/2020
  • NC6620 EXP 02/2020
  • MX1699 EXP 05/2019
  • MX1697 EXP 05/2019

Apo-Perindopril Arginine 5 mg:

  • NC6671 EXP 03/2020
  • NC6670 EXP 03/2020
  • MX1702 EXP 05/2019
  • NC6672 EXP 03/2020

Apo-Perindopril Arginine 10 mg:

  • MX1705 EXP 05/2019
  • MX1703 EXP 05/2019
  • MX1704 EXP 05/2019

All other information and advice provided in the below statement, published 9 November 2017, remains accurate and appropriate.

Recall – potential contamination with particles from desiccant cylinder

Consumers and health professionals are advised that Apotex, in consultation with the TGA, is recalling three batches of Apo-Perindopril Arginine 2.5 mg, 5 mg and 10 mg tablets.

The affected products and batch numbers are:

  • Apo-Perindopril Arginine 2.5 mg – NC6619 EXP 02/2020
  • Apo-Perindopril Arginine 5 mg – NC6671 EXP 03/2020
  • Apo-Perindopril Arginine 10 mg – MX1705 EXP 05/2019

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

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.

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

The dark particles can be seen in the above image as small specks at the bottom of the image and a light dusting on the tablets themselves.

Information for consumers

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.

Information for health professionals

If you treat patients who take Apo-Perindopril Arginine 2.5 mg, 5 mg or 10 mg tablets, please be aware of this issue.

Apotex is writing to pharmacists to provide further information about this issue, including details of the recall procedure. Please inspect your stock and quarantine any bottles of Apo-Perindopril Arginine 2.5 mg, 5 mg and 10 mg tablets from the affected batches.

Patients returning unused or partially used packs should be provided a full refund or offered a replacement from an unaffected batch.

If pharmacists or any other health professionals notice or receive reports of any suspected contamination of other batches of Apo-Perindopril Arginine 2.5 mg, 5 mg or 10 mg tablets, please report it to the TGA (see the ‘Reporting problems’ section below).

If you have any further questions or concerns about this issue, please contact Aptoex on 1800 276 839.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.