Boehringer Ingelheim Korea said it has commenced a voluntary recall of select batches for Spiriva Respimat (ingredient: tiotropium bromide hydrate), its chronic obstructive pulmonary disease (COPD) and asthma medication.

This medication is approved for use as a bronchodilator in the maintenance treatment of COPD and as an add-on maintenance treatment for severe asthma in children over six years and adults with a history of exacerbations in Korea.

The decision for the recall was made following the discovery of defects in the medication indicator of the cartridge within the product. The product comprises a 4.5 ml cartridge and an inhaler, with the drug indicator allowing users to ascertain when cartridge replacement is needed.

According to the MDFS, the recall targets specific manufacturing batches of Spiriva Respimat that are set to expire in August, October, and November 2025.

Regarding the recall, Boehringer Ingelheim Korea clarified that the action is a proactive measure following defect incidents abroad, asserting that there are no safety issues with the medication itself.

“The defect involves the possibility of the drug indicator in the cartridge malfunctioning, where the countdown may stop after approximately ten doses and the inhaler may not lock as expected after sixty doses,” a company official told Korea Biomedical Review. “However, the defect is limited to the drug indicator and does not affect the quality of the medication.”

The official advised that if the product is used according to the instruction manual, safety should not be compromised.

Also, the company stressed that no complaints related to this defect have been reported in Korea.

“The Spiriva Respimat (multidose) is unaffected by the defect are still available, and refill products (cartridge) are expected to be supplied in Korea before the Lunar New Year holiday,” she said. “However, the actual timing of product availability may vary due to distribution processes.

Furthermore, the confirmed that another bronchodilator, Vahelva Respimat, used for symptom relief in adult patients with COPD, is not affected by this defect and continues to be supplied normally.

"We decided on this voluntary recall in consultation with the Ministry of Food and Drug Safety (MFDS) as a preventive measure,” the official said. “We are committed to ensuring that the recall is conducted swiftly and efficiently and to continue our efforts to provide effective medication to patients with COPD and asthma."