HPS Pharmacies wish to give notice that Boehringer Ingelheim, in consultation with the Therapeutic Goods Administration (TGA), has issued a product defect correction for Spiriva® Respimat®, as follows:

Spiriva Respimat Solution for Inhalation
Tiotropium (as bromide monohydrate) 2.5mcg/dose
ARTG 325662

The following batches are affected by this notice:

  • E96634 – expiry October 2025
  • E63130 – expiry December 2025
  • E61076 (samples) – expiry November 2025

This defect alert was initiated following reports of the dose counter stopping after the tenth dose and not locking after the 60th dose. Boehringer Ingelheim advises that the dose counter is still functional, and the device will continue to deliver doses after the tenth dose. However, the counter will not move any further and will still show that only ten doses have been delivered.

Confusion caused by this issue could lead to an overdose (due to the dose counter not changing) or underdose (due to the ‘lock out’ function not working).

Spiriva® Respimat® is not being recalled as this may lead to a supply interruption. Patients should continue to use their medication as prescribed but should be made aware of this issue. If a patient finds that the counter on their device stops after the tenth dose, they should return it to the dispensing pharmacy or contact Boehringer Ingelheim’s Medical Information line on 1800 226 315 to arrange a replacement.

Please inspect your stock and quarantine all affected products. 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 Boehringer Ingelheim on 1800 226 315 or your pharmacist at HPS Pharmacies.

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