Product Alert for Fentanyl GH Ampoules

HPS Pharmacies wish to give notice that Generic Health, in consultation with the Therapeutic Goods Administration (TGA), has issued a product alert Fentanyl GH Solution for Injection as follows:

Fentanyl GH Solution for Injection
Fentanyl 500 microgram/10 mL
ARTG 201871

This product alert was initiated following a report of one ampoule that was found to be damaged within a sealed blister. There was a hole in the tip of the ampoule and a small amount of liquid in the blister casing. Generic Health advises that the defect can be clearly identified. However, a residual risk of fragile ampoule heads with poorly visible damage cannot be fully excluded.

No patient harm has been reported due to this issue.

The only batch affected by this notice is: 40679 (Exp October 2027)

Please inspect each ampoule prior to use. Any ampoules that show signs of damage or structural irregularity should not be used.

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 Generic Health on 03 9780 9700 or your pharmacist at HPS Pharmacies.

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