D-1230-2014 Class III Terminated
FDA drug recall D-1230-2014 was initiated by Boehringer Ingelheim Roxane Inc on March 27, 2014 and is designated Class III. Reason for recall: 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. The recall status is terminated (terminated January 26, 2015). Affected quantity: 1,276,710 Blister Cards.
Recall Details
- Product Type
- Drugs
- Report Date
- April 16, 2014
- Initiation Date
- March 27, 2014
- Termination Date
- January 26, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,276,710 Blister Cards
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
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