Further to DrugAlert Volume 408, HPS Pharmacies wish to advise that Pfizer, in consultation with the Therapeutic Goods Administration (TGA), has given notice of a drug recall for DBL™ Metronidazole Intravenous Infusion as follows:
DBL™ Metronidazole Intravenous Infusion
Metronidazole 500mg/100mL solution for injection bag
All batches within expiry are subject to this drug recall. This action has been initiated following a number of reports of visible black particles, reported as mould, found between the infusion bag and the plastic overwrap. The growth of mould in between the sterile primary bag and the non-sterile overwrap is thought to be the result of leakage of the infusion solution during storage with subsequent accumulation of liquid over prolonged periods.
The potential risk of patient harm is considered to be medium to high owing to the possibility of a systemic infection.
Please inspect your stock and quarantine all DBL™ Metronidazole Intravenous Infusion bags. 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.
This notice replaces DrugAlert Volume 408. 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.