Product Detail

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

Recall Number D-1057-2013

Classification Class III

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

Product Distributed Qty 15,385,232 capsules

Reason For Recall 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

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 Letter

Distribution Pattern Nationwide