Why it was recalled
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
Lot numbers, UPCs & expiration codes
Batch 104440
Where it was sold
Nationwide USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0197-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 26, 2022
- FDA report date
- Jan 3, 2024
- Quantity
- 5 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- CARDINAL HEALTHCARE
Original FDA data
Every field from FDA enforcement report D-0197-2024, exactly as published.
Show all FDA fields
- City
- Dublin
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 89450
- Address
- 7200 Cardinal Pl W
- Code information
- Batch 104440
- Postal code
- 43017-1094
- Report date
- Jan 3, 2024
- Product type
- Drugs
- Recall number
- D-0197-2024
- Classification
- Class II
- Recalling firm
- CARDINAL HEALTHCARE
- Product quantity
- 5 units
- Termination date
- Sep 29, 2024
- Reason for recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Recall initiation date
- Jan 26, 2022
- Initial firm notification
- Letter
- Center classification date
- Dec 26, 2023