FDA recall D-1057-2013

Boehringer Ingelheim Roxane Inc · Class III · drug

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

Reason for recall

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

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2013-08-30
Report date: 2013-09-25
Termination date: 2014-06-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1057-2013