Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) 18 mcg/Capsule Recalled by CARDINAL HEALTHCARE Due to CGMP Deviations: Products were exposed to temperatures outside...

Date: January 26, 2022
Company: CARDINAL HEALTHCARE
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact CARDINAL HEALTHCARE directly.

Affected Products

SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) 18 mcg/Capsule, 30 capsules, 3 blister cards, each card contains 10 capsules, Rx only, For oral inhalation only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. NDC: 0597-0075-41

Quantity: 5 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About CARDINAL HEALTHCARE

CARDINAL HEALTHCARE has 42 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report