Drug Recall Update

 

Further to DrugAlert Volume 377 and DrugAlert Volume 378, HPS Pharmacies wish to advise that Apotex, in consultation with the Therapeutic Goods Administration (TGA), has given notice of a drug recall of four additional batches of APO-Perindopril Arginine as follows:

APO-Perindopril Arginine 2.5mg
Perindopril arginine 2.5mg
ARTG 184808

APO-Perindopril Arginine 5mg
Perindopril arginine 5mg
ARTG 184806

APO-Perindopril Arginine 10mg
Perindopril arginine 10mg
ARTG 184812

The affected batches are as follows:

Product

Batch

Expiry Date

APO-Perindopril Arginine 2.5mg

NC6619

February 2020

NC6620

May 2020

MX1699

May 2019

MX1697

May 2019

MX1698

May 2019

APO-Perindopril Arginine 5mg

NC6671

March 2020

NC6670

March 2020

NC6672

March 2020

MX1700

May 2019

MX1701

May 2019

MX1702

May 2019

APO-Perindopril Arginine 10mg

MX1705

May 2019

MX1704

May 2019

MX1703

May 2019

NC6729

March 2020

 

This recall has been initiated as some bottles from these batches may be contaminated with dark particles of silica. It is presumed that these particles have been released from the desiccant cylinder placed inside the bottle to protect the contents from moisture. The particles may appear as specks or as a dust that discolours the tablets and the inside of the bottle. This potential contamination is classified as a quality defect and is not considered to impact the safety or efficacy of the product.

Please inspect your stock and quarantine any affected batches. If HPS Pharmacies provide imprest management services to your facility, an HPS representative will inspect all stock stored in the designated imprest areas at the earliest opportunity. All affected products will be quarantined for return to the supplier and HPS Pharmacies will arrange for replacement stock as soon as possible. An HPS Pharmacies staff member will contact senior medical and nursing staff if there is an immediate impact to your facility.

Retain this notice in a prominent position, including in other related business units for one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact your pharmacist at HPS Pharmacies, or Apotex on 1800 276 839.

Information regarding expected dates for supply may vary subject to delays which are out of our control. HPS Pharmacies does not accept responsibility for such changes but will endeavour to keep our clients updated as information is made available from drug manufacturers or wholesalers.

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