FDA recall D-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.

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

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2014-03-27

Report date

2014-04-16

Termination date

2015-01-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1230-2014