Boehringer Ingelheim Roxane, based in Columbus, Ohio and a subsidiary of Boehringer Ingelheim, has initiated a voluntary nationwide recall in the United States of certain lots of its Spiriva HandiHaler (tiotropium bromide inhalation powder) capsules 18 mcg per dose (prescription only), according to FDA's weekly enforcement report of Sept. 25, 2013. Spiriva is used to treat chronic obstructive pulmonary disease. The recall is being conducted due to the potential for extrinsic foreign particles in the API used to manufacture Spiriva Handihaler. The product distribution quantity was 15,385,232 capsules, according to the FDA report.
The recall applies to several products types: a 10-count blister (NDC 0597-0075-27), 30-count blister (NDC 0597-0075-41), 90-count blister (NDC 0597-0075-47), and 5-count blister physician sample (NDC 0597-0075-75).
The Class III recall was initiated on Aug. 30, 2013. A Class III recall refers to products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws.