Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Spiriva HandiHaler (tiotropium bromide inhalation powder) For Oral Inhalation Only 18 mcg (as tiotropium) per capsule Rx only NDC 0597-0075-41 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
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 Failed Stability Specifications
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.