US Drug Recall Register
Class III · Low risk Terminated Initiated Mar 27, 2014 (12 years ago)

Spiriva HandiHaler

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Defective Delivery System: Potential for dose delivery out of specification due to interation of the drug product powder with the lubricant on the interior of the capsule shell.

What was recalled

Spiriva HandiHaler (tiotropium bromide inhalation powder), Do Not Swallow Spiriva Capsules, For Use With HandiHaler Only, 18 mcg (as tiotropium) per capsule, Rx Only, a) NDC 0597-0075-75, 5 Spiriva capsules per blister card, b) NDC 0597-0075-41, 30 Spiriva capsules per blister card, Manufactured by: Boehringer Ingelheim (BI) Pharma, GmbH & Co. KG, Ingelheim, Germany, Marketed by: Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT 06877 USA and Pfizer Inc New York, NY 10017 USA, Made in Germany.

Recalling firm
Boehringer Ingelheim Roxane Inc
NDC code
0597-0075-75
Origin
OH, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1230-2014

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Tiotropium recalls

See all
Class II · Moderate risk Terminated

Spiriva Handihaler

Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Cardinal Healthcare D-0197-2024
Class II · Moderate risk Terminated

Spiriva HandiHaler

Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Cardinal Health Inc. NDC 0597-0075-41 D-0453-2021
Class II · Moderate risk Terminated

SPIRIVA HandiHaler

Reason Failed Stability Specifications

Boehringer Ingelheim Pharmaceuticals, Inc. NDC 0597-0075-47 D-0242-2018
Class III · Low risk Terminated

SPIRIVA HandiHaler

Reason 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

Boehringer Ingelheim Roxane Inc NDC 0597-0075-27 D-1057-2013