FDA recall D-0242-2018

Boehringer Ingelheim Pharmaceuticals, Inc. · Class II · drug

Product

SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90 capsules (unit dose blisters) per box, Rx Only, Made in Germany, Distributed by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877, NDC 0597-0075-47

Reason for recall

Failed Stability Specifications

Distribution

Distributed nationwide

Key facts

Status: Terminated
Initiation date: 2017-12-14
Report date: 2018-02-07
Termination date: 2018-10-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Ridgefield, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0242-2018