HPS Pharmacies wish to advise that Pfizer, in consultation with the Therapeutic Goods Administration (TGA), has initiated a drug recall for DBL™ Vancomycin as follows:
This recall has been initiated following the return of out of specification stability results. Affected batches do not meet the shelf-life specification for potency or have atypically declining potency over the 30-month product shelf-life.
No adverse events or product complaints have been reported regarding these batches to date. However, Pfizer advises that there is a reasonable probability that use of impacted product towards the end of its shelf life may reduce its efficacy or contribute to the development of resistance.
The following batches are affected:
- H036913BA (Expiry 08-2022)
- H046913AA (Expiry 01-2023)
- H046913BA (Expiry 01-2023)
- H056913BA (Expiry 01-2023)
Please inspect your stock and quarantine all affected products. 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 Pfizer on 1800 675 229 or your pharmacist at HPS Pharmacies.