HPS Pharmacies wish to advise that Fresenius Kabi, in consultation with the Therapeutic Goods Administration (TGA), has given notice of a drug recall of:
500mg vials, ARTG 196965
1g vials, ARTG 196966
All current batches on the market are affected by this recall. This recall has been initiated due to the identification of a typographical error in the product insert leaflet (PIL). Under ‘Dosage and Administration’, the dosage recommendation for patients with a creatinine clearance of <10ml/min is incorrectly stated as one-half of the unit dose every 12 hours. The correct dosing frequency in this patient group is one-half of the unit dose every 24 hours.
The correct dosing information can be accessed on the TGA website and eMIMS. It is recommended that the correct product information be printed from these sources and kept with the affected stock. Subsequent batches of Meropenem Kabi will contain the correct PIL.
Please inspect your stocks and quarantine all affected products for correction of the PIL.
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.
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 Fresenius Kabi on 1300 361 004.
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.