Drug Recall

 

HPS Pharmacies wish to advise that Pfizer Australia, in consultation with the Therapeutic Goods Administration (TGA), has given notice of a drug recall of:

Pfizer Gentamicin Injection BP
Gentamicin 80mg/2ml
ARTG 11376

The affected batches of 2mL Steriluer ampoules include packs of 10 and 50 ampoules. The affected batches are:

Batch

Expiry Date

A115

30 November 2017

A115A

30 November 2017

A115B

30 November 2017

A129

31 December 2017

A297

31 May 2018

A316

31 August 2018

A318

31 May 2018

A342

31 July 2018

A394

31 October 2018

A448

31 December 2018

 

This recall has been initiated after identification of higher than expected amounts of histamine in the affected batches. Histamine injected intravenously or intramuscularly can lead to signs and symptoms of hypersensitivity reactions, including severe allergic reactions. The risk of this occurring is higher for children and people with severe renal impairment.

Please inspect your stock and quarantine any ampoules from the affected batches. If HPS Pharmacies provide imprest management services to your facility, an HPS representative will arrange a refund for all quarantined stock. Your HPS Pharmacies Pharmacy Manager/Director of Pharmacy will contact your clinicians if there is an immediate impact to your facility.

Retain this notice in a prominent position, including in other related business units until supplies return to normal. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact your pharmacist at HPS Pharmacies, or Pfizer Australia on (02) 9850 3333.

Information regarding expected dates for supply may vary subject to delays which are out of our control. HPS Pharmacies does not accept responsibility for such changes but will endeavour to keep our clients updated as information is made available from drug manufacturers or wholesalers.

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