Spiriva HandiHaler — Class III drug recall D-1230-2014
Terminated recall by Boehringer Ingelheim Roxane Inc, reported 2014-04-16, distributed nationwide. Defective Delivery System: Potential for dose delivery out of specification due to interation of the drug prod
| Recall number | D-1230-2014 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boehringer Ingelheim Roxane Inc, Columbus, OH, United States |
| Recall initiated | 2014-03-27 |
| Classified | 2014-04-10 |
| Reported by FDA | 2014-04-16 |
| Terminated | 2015-01-26 |
| Distributed | Nationwide (US) |
| Quantity | 1,276,710 blister |
| Reason classes | specification failure |
| NDC | 00597-0075, 00597-0075-41, 00597-0075-47, 00597-0075-75 |
| Expiration dates | 2014-09-20, 2014-10-20, 2014-11-20, 2014-12-20 |
Product
Spiriva HandiHaler (tiotropium bromide inhalation powder), Do Not Swallow Spiriva Capsules, For Use With HandiHaler Only, 18 mcg (as tiotropium) per capsule, Rx Only, a) NDC 0597-0075-75, 5 Spiriva capsules per blister card, b) NDC 0597-0075-41, 30 Spiriva capsules per blister card, Manufactured by: Boehringer Ingelheim (BI) Pharma, GmbH & Co. KG, Ingelheim, Germany, Marketed by: Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT 06877 USA and Pfizer Inc New York, NY 10017 USA, Made in Germany.
Reason for recall
Defective Delivery System: Potential for dose delivery out of specification due to interation of the drug product powder with the lubricant on the interior of the capsule shell.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1230-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.