Why it was recalled
Failed Stability Specifications
Product description
SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90 capsules (unit dose blisters) per box, Rx Only, Made in Germany, Distributed by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877, NDC 0597-0075-47
Lot numbers, UPCs & expiration codes
Lot # 606478; Exp. 03/18
Where it was sold
Distributed nationwide
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-0242-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 14, 2017
- FDA report date
- Feb 7, 2018
- Quantity
- 45,008 units/90 capsules each unit
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Boehringer Ingelheim Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0242-2018, exactly as published.
Show all FDA fields
- City
- Ridgefield
- State
- CT
- Status
- Terminated
- Country
- United States
- Event ID
- 78775
- Address
- 900 Ridgebury Rd
- Code information
- Lot # 606478; Exp. 03/18
- Postal code
- 06877-1058
- Report date
- Feb 7, 2018
- Product type
- Drugs
- Recall number
- D-0242-2018
- Classification
- Class II
- Recalling firm
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Product quantity
- 45,008 units/90 capsules each unit
- Termination date
- Oct 17, 2018
- Reason for recall
- Failed Stability Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90 capsules (unit dose blisters) per box, Rx Only, Made in Germany, Distributed by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877, NDC 0597-0075-47
- Distribution pattern
- Distributed nationwide
- Recall initiation date
- Dec 14, 2017
- Initial firm notification
- Letter
- Center classification date
- Jan 26, 2018