TIOTROPIUM BROMIDE MONOHYDRATE Recall D-0197-2024
Description: 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
TIOTROPIUM BROMIDE MONOHYDRATE Recall D-0197-2024 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0197-2024 |
| Event ID | 89450 |
| Brand | SPIRIVA |
| Generic Name | TIOTROPIUM BROMIDE |
| Manufacturer | TIOTROPIUM BROMIDE |
| Original Package? | 1 |
| Active Substance | TIOTROPIUM BROMIDE MONOHYDRATE |
| Drug Route | ORAL |
| Distribution | Nationwide USA |
| Quantity | 5 units |
| Recall Reason | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. |
| Drug Classification | Class II |
| Drug Code Info | 20240103 |
| Product NDC | 0597-0075 |
| Recall Initiation Date | 20220126 |
| Report Date | 20240103 |
| Classification Date | 20231226 |
| Address | 7200 Cardinal Pl W Dublin, OH 43017-1094 United States |
| Recalling Firm | CARDINAL HEALTHCARE |
| Initial Notification | Letter |
| Unique Ingredient Identifier | L64SXO195N |
| Drug Application Number | NDA021395 |
| Structured Product Labeling (SPL ID) | 74c01ed6-9299-467e-bda9-8043c8d887fb |
| Structured Product Labeling (SPL Set ID) | 820839ef-e53d-47e8-a3b9-d911ff92e6a9 |
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