Product Recall for Gelofusine® 500mL

HPS Pharmacies wish to give notice that B Braun, in consultation with the Therapeutic Goods Administration (TGA), has issued a product recall for Gelofusine^® as follows:

Gelofusine^® Ecobag 500mL  
Succinylated gelatin 20g/500mL
ARTG 78102

This product recall was initiated following reports of serious reactions associated with batch 250617641. Investigation has revealed a quality deviation in the manufacturing process which may have resulted in contamination with non-endotoxin pyrogens.

The only batch affected by this notice is: 250617641 (Expiry: 31 January 2027)

Please inspect your stock and quarantine all products from the affected batch. 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 B Braun on 1800 251 705 or your pharmacist at HPS Pharmacies.

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