Spiriva Capsule
FDA Recall NDC 0597-0075
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 5 recorded enforcement report(s) associated with Spiriva (NDC 0597-0075). A significant event, classified as Class II, was initiated on Jan 26, 2022 by Boehringer Ingelheim Pharmaceuticals, Inc.. The reported reason for this action was: "CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Jan 26, 2022
Jan 03, 2024
5 units
Recall Profile & Regulatory Data
Event ID
89450
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
CARDINAL HEALTHCARE
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA
Termination Date
Sep 29, 2024
Product Description
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
Batch or Lot Expiration Information
Batch# Batch 104440
Affected Packages Involved in this Recall
0597-0075-41Product
0597-0075-75Product
0597-0075-47Product
Class II Terminated
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Mar 15, 2021
Jun 02, 2021
2611 inhalers
Recall Profile & Regulatory Data
Event ID
87512
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Cardinal Health Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
FL, GA, SC
Termination Date
Jun 17, 2024
Product Description
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
Batch or Lot Expiration Information
Lot# 5098
Affected Packages Involved in this Recall
0597-0075-41Product
0597-0075-75Product
0597-0075-47Product
Class II Terminated
Failed Stability Specifications
Dec 14, 2017
Feb 07, 2018
45,008 units/90 capsules each unit
Recall Profile & Regulatory Data
Event ID
78775
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Boehringer Ingelheim Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed nationwide
Termination Date
Oct 17, 2018
Product Description
SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90 capsules (unit dose blisters) per box, Rx Only, Made in Germany, Distributed by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877, NDC 0597-0075-47
Batch or Lot Expiration Information
Lot# 606478; Exp. 03/18
Affected Packages Involved in this Recall
0597-0075-41Product
0597-0075-75Product
0597-0075-47Product
Class III Terminated
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.
Mar 27, 2014
Apr 16, 2014
1,276,710 Blister Cards
Recall Profile & Regulatory Data
Event ID
67796
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Boehringer Ingelheim Roxane Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Jan 26, 2015
Product Description
Spiriva HandiHaler (tiotropium bromide inhalation powder), Do Not Swallow Spiriva Capsules, For Use With HandiHaler Only, 18 mcg (as tiotropium) per capsule, Rx Only, a) NDC 0597-0075-75, 5 Spiriva capsules per blister card, b) NDC 0597-0075-41, 30 Spiriva capsules per blister card, 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, Made in Germany.
Batch or Lot Expiration Information
Lot# 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
Affected Packages Involved in this Recall
0597-0075-41Product
0597-0075-75Product
0597-0075-47Product
Class III Terminated
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
Aug 30, 2013
Sep 25, 2013
15,385,232 capsules
Recall Profile & Regulatory Data
Event ID
65428
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Boehringer Ingelheim Roxane Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jun 16, 2014
Product Description
SPIRIVA HandiHaler (Tiotropium Bromide Inhalation Powder) Capsules 18 mcg per dose, Rx only, a) 10 count blister (NDC 0597-0075-27), b) 30 count blister (NDC 0597-0075-41), c) 90 count blister (NDC 0597-0075-47), d) 5 count blister physician sample (NDC 0597-0075-75), Manufactured by: Boehringer Ingelheim (BI) Pharma, GmbH & Co. KG, Ingelheim, Germany
Batch or Lot Expiration Information
Lot# 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, 203660A/Nov-13, 203690A/Nov-13, 203890A/Nov-13, 203980A/Nov-13, 203981B/Nov-13, 204356B/Dec-13, 204357A/Dec-13, 204821A/Dec-13, 204459A/Dec-13, 204552C/Dec-13, 204822A/Dec-13, 204944A/Jan-14, 204947A/Jan-14, 205015A/Jan-14, 205163A/Jan-14, 205364A/Jan-14, 205509A/Feb-14, 205737A/Feb-14, 205571A/Feb-14, 205572A/Feb-14, 205674A/Feb-14, 205682A/Feb-14, 205959A/Feb-14, 205987A/Feb-14, 206186B/Mar-14, 206311A/Mar-14, 206606A/Mar-14, 206944B/Apr-14, 207066A/Apr-14, 206609A/Apr-14, 206729A/Apr-14, 206899A/Apr-14, 206900A/ Apr-14, 207065B/Apr-14, 207191A/May-14, 207199A/May-14, 207352A/May-14, 207420A/May-14, 207577B/May-14, 207691A/May-14, 207692A/May-14, 207778A/May-14, 207818A/Jun-14, 301378A/Jul-14, 301476B/Jul-14, 301699B/Jul-14, 301867A/Aug-14, 202530/Sep-13, 203195A/Oct-13, 203366C/Nov-13, 204067A/Nov-13, 204460B/Dec-13, 204551A/Dec-13, 205260A/Jan-14, 206064B/Mar-14, 206185A/Mar-14, 206939A/Apr-14, 207038A/May-14, 301699A/Jul-14, 202556A/Sep-13, 203569A/Oct-13, 203981A/Nov-13, 204674A/Dec-13, 205737B/Feb-14, 206944A/Apr-14, 207577A/May-14, 301476A/Jul-14 Physician Drug Samples: 203076A/Oct-13, 203891A/Nov-13, 204674B/Dec-13, 205867A/Feb-14, 206731A/Apr-14
Affected Packages Involved in this Recall
0597-0075-41Product
0597-0075-75Product
0597-0075-47Product
0597-0075-27Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
