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‘Dark particles’ prompt recall

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Apotex has announced that, in consultation with the TGA, it 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
It has been identified that some bottles from these batches of the blood pressure treatment 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 image below as small specks at the bottom of the image and a light dusting on the tablets themselves.


Apotex is writing to pharmacists to provide further information about this issue, including details of the recall procedure.They advise to 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, they are asked to report it to the TGA.

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

 

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