FDA Drug · D-0453-2021

Spiriva HandiHaler (tiotropium bromide inhalation powder) For Oral Inhalation Only 18 mcg (as tiotropium) per capsule Rx only NDC 0597-0075-41 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

Class II · Terminated

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Affected lots / codes — check yours against this5098

Recalling firm: Cardinal Health Inc., Dublin, OH
Classification: Class II (temporary or reversible harm possible)
Status: Terminated
Quantity: 2611 inhalers
Distribution: FL, GA, SC
Recall initiated: March 15, 2021
Classified: May 24, 2021
Terminated: June 17, 2024
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0453-2021%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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