Reported Feb 7, 2018 · Terminated

SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90 capsules (unit dose blisters) per box, Rx…

Boehringer Ingelheim Pharmaceuticals, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Boehringer Ingelheim Pharmaceuticals, Inc. · 900 Ridgebury Rd · Ridgefield, CT · 06877-1058

Is this the product you have?

  • SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90 capsules (unit dose blisters) per box, Rx Only, Made in Germany
  • Distributed byBoehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877, NDC 0597-0075-47
Lot codes and dates
    • Lot # 606478
    • Exp. 03/18
Amount recalled
45,008 units/90 capsules each unit

Where it was sold

  • Nationwide

Why it was recalled

Failed Stability Specifications

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Oct 17, 2018 · Data as of Sep 19, 8:05 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.