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

Recall Number: D-1057-2013

Firm: Boehringer Ingelheim Roxane Inc

Classification: Class III

Status: Terminated

Report Date: 20130925

Initiation Date: 20130830

Termination Date: 20140616

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

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