HPS Pharmacies wish to give notice that GlaxoSmithKline Australia, in consultation with the Therapeutic Goods Administration (TGA), has issued a product correction for Flixotide® and Pavtide® Accuhalers:
| Product | ARTG | Affected batches |
|---|---|---|
| Flixotide® 100mcg | 58437 | PA8S (Exp: 17/09/2027) |
| Flixotide® 250mcg | 58438 | HM6D (Exp: 04/06/2028)
PA8V (Exp: 16/09/2028) |
| Flixotide® 500mcg | 58439 | DT5H (Exp: 26/03/2028) |
| Pavtide® 100/50mcg | 208200 | SJ5R (Exp: 24/10/2027) |
| Pavtide® 250/50mcg | 208201 | SD3C (Exp: 22/10/2027) |
This product correction was initiated as some Accuhalers have not been automatically reloading when the device is rotated after use (as shown in the images below). If the dose is not manually reset, this may lead to a short-term flare-up of asthma symptoms. No defects have been observed in the market to date, and the products are not being recalled.
Patients should continue to use their device as prescribed. If a device does not automatically reset, patients should manually reset the starting position by pushing the lever down towards the mouthpiece prior to each dose (as shown in Figure 2). The sponsor advises patients to check that the dose counter has advanced to ensure the dose has been delivered.
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 GlaxoSmithKline on 1800 033 109 or your pharmacist at HPS Pharmacies.
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