FDA Drug recall D-1057-2013
SPIRIVA HandiHaler (Tiotropium Bromide Inhalation Powder) Capsules 18 mcg per dose, Rx only, a) 10 count blister (NDC 0597-0075-27), b) 30…
- FDA Drug
- Class III
- terminated
- Published 2013-09-25
On 2013-09-25 the FDA classified a Class III recall of SPIRIVA HandiHaler (Tiotropium Bromide Inhalation Powder) Capsules 18 mcg per dose, Rx only, a) 10 count blister (NDC 0597-0075-27), b) 30… by Boehringer Ingelheim Roxane, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1057-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-08-30 |
| Published | 2013-09-25 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Boehringer Ingelheim Roxane |
| Distribution | US |
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
Reason
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
Identifiers
| ndc | 0597-0075-41 |
|---|---|
| ndc | 0597-0075-75 |
| ndc | 0597-0075-47 |
| ndc | 0597-0075-27 |
| code_info | Lot Number/Exp. Date: 202477A/Sep-13, 202480A/Sep-13, 202556B/Sep-13, 202603A/Sep-13, 202784B/Sep-13, 202844A/Sep-13,…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, |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1057-2013%22
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