Recall widens again


recall regulatory

The Apo-Perindopril Arginine recall has been widened for a second time, affecting four more batches

Apotex, in consultation with the TGA, is recalling four more batches of the blood pressure drug, in addition to the 11 batches already under recall.

The recall relates to the possibility that some bottles from these batches of the medicine 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 newly affected batches are:

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

Apotex has asked pharmacists to inspect their 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, it says.

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