Apotex Apo-Perindopril Arginine Recall Expands [Australia]


Australia FlagAustralia/Canberra: Apotex Apo-Perindopril Arginine Recall Expands [Australia]Apotex Pty Ltd. expands its existing recall for certain batch/lots of Apo-Perindopril Arginine drugs used to treat High Blood Pressure, Heart Failure or Coronary Artery Disease to include additional batch/lots of the drug. The original recall was due to suspected silica contamination, a possible health and safety hazard. ACCC: http://ht.ly/PgEM30gRd38

Direct link: https://www.productsafety.gov.au/recall/apotex-pty-ltd-apo-perindopril-arginine-25-mg-5-mg-and-10-mg-tablets-bottle-extended-recall-new-batches

Additional information:
The Australian Competition & Consumer Commission (“ACCC”) reports the following Drugs are subject to this recall:

Eleven (11) batches of APO-Perindopril Arginine are affected by this recall:

  • APO-Perindopril Arginine 2.5 mg tablets; DIN: AUST R: 184808
    • 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
  • APO-Perindopril Arginine 5 mg tablets; DIN: AUST R: 184806
    • Batch/lot number: (L)NC6671; expiry: 03/2020
    • Batch/lot number: (L)NC6670; expiry: 03/2020
    • Batch/lot number: (L)MZ1702; expiry: 05/2019
    • Batch/lot number: (L)NC6672; expiry: 03/2020
  • APO-Perindopril Arginine 10 mg tablets; DIN: AUST R: 184812
    • Batch/lot number: (L)MX1705; expiry: 05/2019
    • Batch/lot number: (L)MX1703; expiry: 05/2019
    • Batch/lot number: (L)MX1704; expiry: 05/2019

==> No barcodes, UPCs, APNs or other identification numbers were listed with this recall notification.

Please consult the photograph above for details of the drug’s packaging, design and retail presentation.

According to the ACCC, some bottles from the recalled 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.

At the time of this recall notification, Australia’s Therapeutic Goods Administration classified this potential contamination as a quality defect and is not considered to impact product safety or efficacy.

If you believe you have purchased or have in your possession and of the recalled Drugs, please do not consume them. Instead, kindly return the product to the pharmacy or where you purchased it for a full refund.

Please note: this is an expansion of an earlier recall for this drug product. To see all notifications regarding this drug, please search for “APO-Perindopril” using the Search Box at the top of this page.

==> To see other recalls and notifications relating to Drugs, please search for “drug” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and or sold by Apotex Pty Ltd, please search for “Apotex” using the Search Box at the top of this page.

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More information about this recall:
ACCC PRA number: 2017/16424
Recalls Direct RIN: 9504-2017
Want to read more about this recall?
==> Please click on the links above to visit the originating site.
Want to read more about other recalls?
==> Please click on the links below.

General information:
More recalls? Back to the main Recalls Direct page:
==> http://www.RecallsDirect.com/
About the Recalls Direct service:
==> http://wp.me/P2bVty-2
Visit the Living Safely site:
==> http://www.LivingSafely.org/
Report an unsafe product you purchased in Australia [external: new window opens]:
==> https://www.productsafety.gov.au/contact-us/for-consumers/report-an-unsafe-product
Search for a recalled product on the ACCC Web site [external: new window opens]:
==> http://www.productsafety.gov.au/recalls/browse-all-recalls

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E. & O. E.

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