Reported Sep 25, 2013 · Terminated
SPIRIVA HandiHaler (Tiotropium Bromide Inhalation Powder) Capsules 18 mcg per dose, Rx only, a) 10 count blister (NDC…
Boehringer Ingelheim Roxane Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boehringer Ingelheim Roxane Inc · 1809 Wilson Rd · Columbus, OH · 43228-9579
Is this the product you have?
4 of 4 products
| # | Product as published |
|---|---|
| 1 | 10 count blister (NDC 0597-0075-27) |
| 2 | 30 count blister (NDC 0597-0075-41) |
| 3 | 90 count blister (NDC 0597-0075-47) |
| 4 | 5 count blister physician sample (NDC 0597-0075-75), Manufactured by: Boehringer Ingelheim (BI) Pharma, GmbH & Co. KG, Ingelheim, Germany |
- Lot codes and dates
- Lot Number/Exp
- Date
86 of 86 codes
202477A/Sep-13202480A/Sep-13202556B/Sep-13202603A/Sep-13202784B/Sep-13202844A/Sep-13202951A/Sep-13203041A/Sep-13203042ASep-13203280A/Oct-13203281A/Oct-13203364A/Oct-13203440AOct-13203569B/Oct-13203588A/Oct-13203890B/Nov-13204094A/Nov-13203660A/Nov-13203690A/Nov-13203890A/Nov-13203980A/Nov-13203981B/Nov-13204356B/Dec-13204357A/Dec-13204821A/Dec-13204459A/Dec-13204552C/Dec-13204822A/Dec-13204944A/Jan-14204947A/Jan-14205015A/Jan-14205163A/Jan-14205364A/Jan-14205509A/Feb-14205737A/Feb-14205571A/Feb-14205572A/Feb-14205674A/Feb-14205682A/Feb-14205959A/Feb-14205987A/Feb-14206186B/Mar-14206311A/Mar-14206606A/Mar-14206944B/Apr-14207066A/Apr-14206609A/Apr-14206729A/Apr-14206899A/Apr-14206900A/ Apr-14207065B/Apr-14207191A/May-14207199A/May-14207352A/May-14207420A/May-14207577B/May-14207691A/May-14207692A/May-14
- Physician Drug Samples
203076A/Oct-13203891A/Nov-13204674B/Dec-13205867A/Feb-14206731A/Apr-14
- Amount recalled
- 15,385,232 capsules
Where it was sold
- Nationwide
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
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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