Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
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.
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.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason Failed Stability Specifications
Reason Presence of Foreign Substance: This recall is being conducted due to the potential for extrinsic foreign particles in the API used to manufacture…
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