Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Failed Stability Specifications
SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90 capsules (unit dose blisters) per box, Rx Only, Made in Germany, Distributed by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877, NDC 0597-0075-47
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 Defective Delivery System: Potential for dose delivery out of specification due to interation of the drug product powder with the lubricant on the…
Reason Presence of Foreign Substance: This recall is being conducted due to the potential for extrinsic foreign particles in the API used to manufacture…
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.