15 FDA recalls mention Ipratropium. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Ipratropium.
Reason Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Reason cGMP deviations: Temperature abuse
Reason cGMP deviations: Temperature abuse
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Reason Lack of Processing Controls
Reason Lack of Processing Controls
Reason Lack of Processing Controls
Reason Lack of Processing Controls
Reason Lack of Processing Controls
Reason Lack of Processing Controls
Reason Lack of Processing Controls
Reason Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process
Reason Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray.
Reason Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality…
Reason Label Mix up; side panel of sticker label applied by Dispensing Solutions Inc. incorrectly indicates product name as Ventolin HFA 90 mcg instead of…
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