Drug Availability

 

HPS Pharmacies wish to advise that Pfizer Pty Ltd, following an internal investigation and in consultation with the Therapeutic Goods Administration (TGA), has given notice of a drug recall of the following Metronidazole DBL 500mg infusion bag:

Product

ARTG

Lot Number

Expiry Date

Metronidazole DBL 500mg infusion bag 100ml x10

129476

70094

March 2019

 

This recall has been initiated due to a customer report that a single unit from a 10 unit box of Metronidazole DBL 500mg infusion bag 100ml, batch 70094, had visible black particles reported as mould between the infusion bag (primary packaging) and the plastic overwrap (secondary packaging).

The potential risk to a patient arising from the unlikely exposure to impacted metronidazole products is considered to be medium to high, particularly for immunocompromised patients.

There is no evidence of impact to other batches distributed and one hundred percent re-inspection by Pfizer of all batches from the third party manufacturer will be undertaken to ensure any impacted, or potentially leaking bags, are identified and removed.

Please inspect your stock and quarantine all affected products from the batch stated above. If HPS Pharmacies provide imprest management services to your facility, an HPS representative will inspect all stock stored in the designated imprest areas at the earliest opportunity. All affected products will be quarantined for return to the supplier and HPS Pharmacies will arrange for replacement stock as soon as possible. An HPS Pharmacies staff member will contact senior medical and nursing staff if there is an immediate impact to your facility.

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 on 1800 675 229.

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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