Drug Recall for Flumazenil-Baxter

HPS Pharmacies wish to advise that Baxter Healthcare, in consultation with the Therapeutic Goods Administration (TGA), has issued a drug recall of the following product:

Flumazenil-Baxter Ampoules
Flumazenil 0.5 mg/5 mL
ARTG 231405

This recall was initiated following the detection of an out-of-specification result for an impurity during 3-month stability testing. Subsequent investigation confirmed the impurity to be furosemide. No adverse events associated with this issue have been reported.

The only affected lot is: B5J0078A

Please inspect your stock and quarantine all products from the affected lot. 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 Baxter Healthcare on 1800 229 837, or your pharmacist at HPS Pharmacies.

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