HPS Pharmacies wish to advise that Pfizer, in consultation with the Therapeutic Goods Administration (TGA), has given notice of a product defect alert 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 product defect alert. This action has been initiated as a single injection bag was reported to have visible black particles, reported as mould, 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. However, the complaint that initiated this alert was the first instance of a primary bag leak of this sort in the last ten years. It is, therefore, considered likely to be an isolated event.
Like all parenteral products, it is important to remember to visually inspect each product before use. Each IV bag should undergo a manual ‘squeeze test’ immediately prior to use to ensure there are no leaks. If moisture, mould, or any other anomaly is detected, that bag must be quarantined.
Please inspect your stock and quarantine any affected 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.
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.