Recalls / Class III
Class IIID-1230-2014
Product
Spiriva HandiHaler (tiotropium bromide inhalation powder), Do Not Swallow Spiriva Capsules, For Use With HandiHaler Only, 18 mcg (as tiotropium) per capsule, Rx Only, a) NDC 0597-0075-75, 5 Spiriva capsules per blister card, b) NDC 0597-0075-41, 30 Spiriva capsules per blister card, Manufactured by: Boehringer Ingelheim (BI) Pharma, GmbH & Co. KG, Ingelheim, Germany, Marketed by: Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT 06877 USA and Pfizer Inc New York, NY 10017 USA, Made in Germany.
- Brand name
- Spiriva
- Generic name
- Tiotropium Bromide
- Active ingredient
- Tiotropium Bromide Monohydrate
- Route
- Oral, Respiratory (inhalation)
- NDC
- 0597-0075
- FDA application
- NDA021395
- Affected lot / code info
- a) 5 count capsule blister card: 303012A, Exp Sep 2014; b) 30 count capsules blister card: 303012B, Exp Sep 2014, 303125A, 303253A, Exp Oct 2014, 303895A, 304282A, Exp Nov 2014, 304510A, Exp Dec 2014
Why it was recalled
Defective Delivery System: Potential for dose delivery out of specification due to interation of the drug product powder with the lubricant on the interior of the capsule shell.
Recalling firm
- Firm
- Boehringer Ingelheim Roxane Inc
- Manufacturer
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1809 Wilson Rd, N/A, Columbus, Ohio 43228-9579
Distribution
- Quantity
- 1,276,710 Blister Cards
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2014-03-27
- FDA classified
- 2014-04-10
- Posted by FDA
- 2014-04-16
- Terminated
- 2015-01-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1230-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.