SpirivaHandiHaler 18 ug capsule

Where it's made

This label doesn't name the factory that makes the drug. Companies don't have to print it on the label. The maker's name is often on the stock bottle your pharmacy used; you can ask the pharmacist. See the plants Boehringer Ingelheim Pharmaceuticals, Inc. names for other drugs.

Recalls

• Jan 26, 2022 · Class II · Cardinal Healthcare
  CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
  Lots: Batch 104440
• Mar 15, 2021 · Class II · Cardinal Health Inc.
  CGMP Deviations: Intermittent exposure to temperature excursion during storage.
  Lots: 5098
• Dec 14, 2017 · Class II · Boehringer Ingelheim Pharmaceuticals, Inc.
  Failed Stability Specifications
  Lots: Lot # 606478; Exp. 03/18
• Mar 27, 2014 · Class III · Boehringer Ingelheim Roxane Inc
  Defective Delivery System: Potential for dose delivery out of specification due to interation of the drug product powder with the lubricant on the interior of the capsule shell.
  Lots: a) 5 count capsule blister card: 303012A, Exp Sep 2014; b) 30 count capsules blister card: 303012B, Exp Sep 2014, 303125A, 303253A, Exp Oct 2014, 303895A, 304282A, Exp Nov 2014, 304510A, Exp Dec 2014
• Aug 30, 2013 · Class III · Boehringer Ingelheim Roxane Inc
  Presence of Foreign Substance: This recall is being conducted due to the potential for extrinsic foreign particles in the API used to manufacture SPIRIVA Handihaler
  Lots: Lot Number/Exp. Date: 202477A/Sep-13, 202480A/Sep-13, 202556B/Sep-13, 202603A/Sep-13, 202784B/Sep-13, 202844A/Sep-13, 202951A/Sep-13, 203041A/Sep-13, 203042A,Sep-13, 203280A/Oct-13, 203281A/Oct-13, 203364A/Oct-13, 203440A,Oct-13, 203569B/Oct-13, 203588A/Oct-13, 203890B/Nov-13, 204094A/Nov-13, …

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.

Product details

Generic drug

Tiotropium: every company that makes it

Form

capsule, oral; respiratory (inhalation)

Strength

18 ug

Approval

NDA NDA021395

On the market since

Oct 11, 2005

Package NDCs

0597-0075-41 0597-0075-47 0597-0075-75

Official label

DailyMed (National Library of Medicine), updated Nov 10, 2025

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