CARDINAL HEALTHCARE: Drug Recall
Recall #D-0197-2024 · 01/26/2022
Class II: Risk
Recall Details
- Recall Number
- D-0197-2024
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- CARDINAL HEALTHCARE
- Status
- Terminated
- Date Initiated
- 01/26/2022
- Location
- Dublin, OH, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 units
Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Product 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
Distribution Pattern
Nationwide USA
Other Recalls by CARDINAL HEALTHCARE
- Class II: Risk 01/26/2022
- Class II: Risk 01/26/2022
- Class II: Risk 01/26/2022
- Class II: Risk 01/26/2022
- Class II: Risk 01/26/2022
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.