Boehringer Ingelheim Roxane Inc recalls SPIRIVA HandiHaler (Tiotropium Bromide Inhalation Powder) Capsules 18 mcg per dose, Rx only, a) 10 count blister (NDC 05
Recalled September 25, 2013 · FDA recall D-1057-2013 · Boehringer Ingelheim Roxane
Hazard
Presence of Foreign Substance: This recall is being conducted due to the potential for extrinsic foreign particles in the API used to manufacture SPIRIVA Handihaler · FDA Class III
Units
15,385,232 capsules
Sold at
Nationwide
Description
Presence of Foreign Substance: This recall is being conducted due to the potential for extrinsic foreign particles in the API used to manufacture SPIRIVA Handihaler
Product
SPIRIVA HandiHaler (Tiotropium Bromide Inhalation Powder) Capsules 18 mcg per dose, Rx only, a) 10 count blister (NDC 0597-0075-27), b) 30 count blister (NDC 0597-0075-41), c) 90 count blister (NDC 0597-0075-47), d) 5 count blister physician sample (NDC 0597-0075-75), Manufactured by: Boehringer Ingelheim (BI) Pharma, GmbH & Co. KG, Ingelheim, Germany
Manufacturer(s)
Boehringer Ingelheim Roxane Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →