SPIRIVA HANDIHALER — Class II drug recall D-0197-2024
Terminated recall by CARDINAL HEALTHCARE, reported 2024-01-03, distributed nationwide. CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
| Recall number | D-0197-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CARDINAL HEALTHCARE, Dublin, OH, United States |
| Recall initiated | 2022-01-26 |
| Classified | 2023-12-26 |
| Reported by FDA | 2024-01-03 |
| Terminated | 2024-09-29 |
| Distributed | Nationwide (US) |
| Quantity | 5 units |
| Reason classes | labeling, cgmp |
| NDC | 00597-0075, 00597-0075-41, 00597-0075-47, 00597-0075-75 |
| Lot numbers | 104440 |
Product
SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) 18 mcg/Capsule, 30 capsules, 3 blister cards, each card contains 10 capsules, Rx only, For oral inhalation only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. NDC: 0597-0075-41
Reason for recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
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-0197-2024. 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.