Drug recall D-0453-2021

Class II Terminated reported Jun 2, 2021

Product

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

Reason for recall

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Lots and codes

5098

Recall details

Recalling firm
Cardinal Health Inc., Dublin, OH
Quantity
2611 inhalers
Distribution
FL, GA, SC
Type
Voluntary: Firm initiated
Recall initiated
March 15, 2021
Terminated
June 17, 2024

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