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
Reported: February 7, 2018 Initiated: December 14, 2017 #D-0242-2018
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
Reason for Recall
Failed Stability Specifications
Details
- Recalling Firm
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Units Affected
- 45,008 units/90 capsules each unit
- Distribution
- Distributed nationwide
- Location
- Ridgefield, CT
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Boehringer Ingelheim Pharmaceuticals, Inc.. Units affected: 45,008 units/90 capsules each unit.
Why was this product recalled? ▼
Failed Stability Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 7, 2018. Severity: Moderate. Recall number: D-0242-2018.
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