Australia : DBL METRONIDAZOLE INTRAVENOUS INFUSION metronidazole 500mg/100mL solution for injection bag - Product defect alert (English Only)
 
Therapeutic Goods Administration (TGA) announces that Pfizer Australia Pty Ltd has issued a product defect alert for all batches of “DBL METRONIDAZOLE INTRAVENOUS INFUSION metronidazole 500mg/100mL solution for injection bag”. 

In February 2018, a customer reported that a single unit of DBL METRONIDAZOLE INTRAVENOUS INFUSION INJECTION metronidazole 500mg/100mL (from a 10 unit box) showed visible black particles reported as mould between the infusion bag (primary packaging) and plastic overwrap (secondary packaging). 

The unlikely growth of mould between the primary (bag) and secondary bag is considered a direct result of the primary bag slowly leaking over time and the accumulation of the leaked solution in a non-sterile overwrap bag. 

Further evaluation of the primary container confirmed that the leak is the result of pre-existing damage to the polycarbonate stopper, which is supplied by a third party. 

It is instructed that all DBL METRONIDAZOLE INTRAVENOUS INFUSION metronidazole 500mg/100mL solution for injection bags should require a manual squeeze test to check for the presence of leaks in the primary container after removal of secondary overwrap packaging. If any visible moisture, liquid or mould is detected either before or after removal of the primary bag from the overwrap, in DBL METRONIDAZOLE INTRAVENOUS INFUSION metronidazole 500mg/100mL solution for injection bags, it is advised to discard the product and report the incident to responsible company. 

Please refer to the following website in TGA for details: http://apps.tga.gov.au/../arn-detail.aspx?k=RC-2018-RN-00641-1 

In Hong Kong, the above product is not a registered pharmaceutical product. 


Ends/ Wednesday, June 6, 2018 
Issued at HKT 17:45 

轉載自衛生署藥物辦公室網頁http://www.drugoffice.gov.hk/