Drug Recall for Product Correction

 

Further to DrugAlert Volume 358, HPS Pharmacies wish to advise that Pfizer Australia, in consultation with the Therapeutic Goods Administration (TGA), has given notice of a drug recall for product correction of:

Pfizer Heparin Injection Ampoules
5000 IU in 5ml
ARTG 49232

Pfizer Lignocaine Ampoules
50mg in 5ml
ARTG 49296

The only affected batches are as follows:

Heparin – A473 with an expiry date of February 2019.

Lignocaine – A313 with an expiry date of November 2017.

This recall for product correction was initiated after one patient discovered lignocaine ampoules in a newly opened box of Pfizer Heparin 5000 IU in 5ml. Both products, manufactured by Pfizer, are of similar appearance. This is believed to be an isolated case and the chances of finding more affected batches is considered low. However, Pfizer is requesting that you visually inspect the contents of product in the affected batches. If any irregularities are found, these products should be immediately quarantined before returning to the wholesaler.

If HPS Pharmacies provide imprest management services to your facility, an HPS representative will inspect your stock and quarantine all affected products for correction. Your HPS Pharmacies Pharmacy Manager/Director of Pharmacy will contact your clinicians if there is an immediate impact to your facility.

Product that has been inspected and found to contain the correct medication may be used and supplied as normal until the expiry date printed on the ampoules.

Retain this notice in a prominent position, including in other related business units for one month. 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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