Medicine recalls
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| Australia: Recall: Apo-Perindopril Arginine – potential contamination with particles from desiccant cylinder |
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The Therapeutic Goods Administration (TGA) advises consumers and health professionals that Apotex, in consultation with the TGA, is recalling three batches of Apo-Perindopril Arginine 2.5mg, 5mg and 10mg tablets. The affected products and batch numbers are:
- Apo-Perindopril Arginine 2.5mg – NC6619 (EXP 02/2020)
- Apo-Perindopril Arginine 5mg – NC6671 (EXP 03/2020)
- Apo-Perindopril Arginine 10mg – 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.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/alert/apo-perindopril-arginine
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Friday, Nov 10, 2017
Issued at HKT 14:00
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