FDA-Drug2013-09-25Class III
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
Boehringer Ingelheim Roxane Inc
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
Sold states
Nationwide
Affected count
15,385,232 capsules
Manufactured in
1809 Wilson Rd, N/A, Columbus, OH, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1057-2013Don't want to check this manually?
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