FW: Alert escalated to a recall : Check for mould on MYX brand Linezolid IV bags batch number ZW701

[Glenys Harrington]

Dear All,

Please note that this QUARANTINE has been escalated to a RECALL – see TGA
web page with the following information

http://apps.tga.gov.au/PROD/SARA/arn-report.aspx

“Mayne Pharma International has confirmed presence of dark mould on the
exterior of the primary bag on several lots of LINEZOLID MYX linezolid 600
mg/300 mL injection infusion bag following a customer complaint received
Monday July 16.
The manufacturer of these bags has identified a probable root cause for the
contamination, which at present is isolated to the exterior of the primary
bag. However, this issue may pose a contamination risk on administration,
particularly for immunocompromised patients. Corrective actions will be put
in place for future lots which have been requested urgently to replace
current stock.

To date, no reports of adverse events or other complaints have been received
either by Mayne Pharma or the manufacturer regarding this product”.

Regards

Glenys

Glenys Harrington

Infection Control Consultancy (ICC)

P.O. Box 6385

Melbourne

Australia, 3004

M: +61 404816434

E: infexion@ozemail.com.au

number ZW701

Dear Ozbug and ACIPC Members,

Find attached the TGA and the Mayne Pharma International Pty Ltd URGENT
MEDICINE QUARANTINE notices

regards

Glenys

Glenys Harrington

Infection Control Consultancy (ICC)

P.O. Box 6385

Melbourne

Australia, 3004

M: +61 404816434

E: infexion@ozemail.com.au

number ZW701

Dear All,

Further to below the Australasian College of Prevention and Control (ACIPC)
are holding off posting this Alert from Safer Care Victoria (Health
Victoria) for now as they believe ” it should come from TGA /manufacturer as
an alert or recall”.

As this may have patient safety implications can I request that you pass the
Alert below and attached photographs onto your infection control
colleagues.

Many thanks in anticipation.

Regards

Glenys

Glenys Harrington

Infection Control Consultancy (ICC)

P.O. Box 6385

Melbourne

Australia, 3004

M: +61 404816434

E: infexion@ozemail.com.au

number ZW701

Dear All,

See below the alert and attached images posted today.

The supplier of the medicine in the images is Mayne Pharma.

I have notified the TGA Recalls Section, Manufacturing Quality Branch.

You should check if you have Linezolid IV bags from the above supplier in
stock and if so review stock packaging looking for anything that may
resemble mould – see images attached.

When medicine are identified with possible contamination the Therapeutic
Goods Administration(TGA), Manufacturing Quality Branch should be notified.

See contact details at the following link:

https://www.tga.gov.au/manufacturing-therapeutic-goods#contacts

regards

Glenys

Glenys Harrington

Infection Control Consultancy (ICC)

P.O. Box 6385

Melbourne

Australia, 3004

M: +61 404816434

E: infexion@ozemail.com.au

[mailto:Kylie.McIntosh@safercare.vic.gov.au]
ZW701

Dear Victorian AMS contacts & Directors of Pharmacy,

There have been reports (via the pharmacy ID email discussion group) from
the Northern Territory that MYX brand Linezolid IV bags from batch number
ZW701 have had mould discovered inside the foil packaging directly on the
bags. The problem has been reported to the manufacturer. See attached
photos.

If you hold the MYX brand of Linezolid, please check stocks immediately and
take appropriate action,

Kind regards,

Kylie

Dr Kylie McIntosh
Principal Policy Officer – Medicines (Tues/Wed/Thurs)

T 03 9096 7786
E kylie.mcintosh@safercare.vic.gov.au
W safercare.vic.gov.au

Please note that I work from home on Thursdays and am contactable on ph:
0413 605377

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