Recalls / Class III
Class IIID-1057-2013
Product
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
- Brand name
- Spiriva
- Generic name
- Tiotropium Bromide
- Active ingredient
- Tiotropium Bromide Monohydrate
- Route
- Oral, Respiratory (inhalation)
- NDC
- 0597-0075
- FDA application
- NDA021395
- Affected lot / code info
- 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
Why it was recalled
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
Recalling firm
- Firm
- Boehringer Ingelheim Roxane Inc
- Manufacturer
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1809 Wilson Rd, N/A, Columbus, Ohio 43228-9579
Distribution
- Quantity
- 15,385,232 capsules
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-08-30
- FDA classified
- 2013-09-16
- Posted by FDA
- 2013-09-25
- Terminated
- 2014-06-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1057-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.