FDAFDA · Food and drugs·Recall number D-1230-2014
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.
Published April 16, 2014 · Recall initiated: March 27, 2014
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
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- SPIRIVA
- Manufacturer
- Boehringer Ingelheim Roxane Inc
- Distributor
- Nationwide and Puerto Rico
- Lot
- 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
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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