Important notice: Infanrix hexa-vaccine medicine recall

[Claire Boardman]

FYI – if you are a registered immuniser.

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Infanrix hexa vaccine
Medicine recall

GlaxoSmithKline (GSK) Australia following consultation with the Therapeutic Goods Administration (TGA) is voluntarily recalling for quality reasons the above batches of Infanrix hexa which were dispatched from GSK between August 2011 and January 2012.

Reason for recall:
This recall is a precautionary measure following quality control testing of the surrounding environment for one of the manufacturing steps where a surface was found to have minor residual contamination with Bacillus cereus, an organism commonly found in food and soil.

No such contamination has been found in the ingredients or finished vaccine itself and all the batches subsequently passed the quality and sterility testing required to be released for use in Australia.

Based on release specifications and safety report monitoring, GSK believes the efficacy and safety profile of the vaccine remains unchanged and does not believe this issue poses a health risk to patients.

The affected batches are listed in the following table:

Batch Number Expiry Date
A21CB144A 31 January 2014
A21CB188D 31 January 2014
A21CB188E 31 January 2014
A21CB190A 31 January 2014
A21CB197A 31 January 2014
A21CB221B 31 January 2014

No other batches of Infanrix hexa or any other GSK vaccines are affected by this recall. If you have a pack of Infanrix hexa from any of the recalled batches do not use it.

GSK maintains a global database of adverse events reported for medicines and vaccines manufactured by the company. A search of this database has found no change in reporting pattern since the identified batches have been released. None of the reported adverse events have been directly linked to this issue. GSK continually monitors all incoming reports of spontaneous adverse events for Infanrix hexa to identify safety concerns in a timely manner.

Post Immunisation Patient Follow-up

Patients to whom doses from the identified batches have already been administered do not require additional monitoring beyond routine post-immunisation processes. Patients already vaccinated do not require re-vaccination. As usual any adverse events following immunisation should be reported to GSK Medical Information on 1800 033 109.

Adverse events should also be reported to State and Territory Health Authorities or directly to the TGA. For more details, please see the Australian Adverse Drug Reaction Reporting System at http://www.ebs.tga.gov.au/ebs/ADRS/ADRSRepo.nsf?OpenDatabase.

If you have received any of the recalled stock as part of the National Immunisation Program:

1. Please isolate and do not dispense/administer any further doses of these Infanrix hexa batches.
2. You will receive replacement Infanrix hexa vaccine.
3. You will be contacted by GSK regarding collection of the recalled stock.

If you have purchased recalled stock from a pharmaceutical or surgical wholesaler, or received stock via any other means:

1. Please isolate and do not dispense/administer any further doses of these Infanrix hexa batches.
2. Contact GSK directly on 1800 064 162 for instructions concerning collection and replacement of the recalled stock.

Hospitals / Pharmacies
If any recalled stock could have been transferred from your hospital or pharmacy to another location, please immediately let them know of this recall. It would be appreciated if you would then telephone GSK on 1800 064 162 with their details so that GSK can contact them directly.

Once again, GSK is committed to the highest quality standards and has decided solely as a precautionary measure to initiate this voluntary recall of identified batches.
We sincerely regret any inconvenience caused by this recall. Should you require any additional information, please contact GSK on 1800 064 162.

Reporting problems to the TGA
Consumers and health professionals are encouraged to report problems with medicines and vaccines. Your report will contribute to our monitoring of these products.
The TGA cannot give personal advice about an individual’s medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine, vaccine or medical device.

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