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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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Event Detail

Event ID 65428
Product Type Drugs
Status Ongoing
Recalling Firm Boehringer Ingelheim Roxane Inc
City Columbus
State OH
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-30
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 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 Class III 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 15,385,232 capsules D-1057-2013