5 FDA recalls mention Tiotropium. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Tiotropium.
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 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…
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