FDAFDA · Food and drugs·Recall number D-0197-2024
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
Published January 3, 2024 · Recall initiated: January 26, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- SPIRIVA
- Manufacturer
- CARDINAL HEALTHCARE
- Distributor
- Nationwide USA
- Lot
- Batch 104440
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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