Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Defective Delivery System: There is a potential for some units in certain lots of Qnasl Nasal Aerosol 80 mcg metered spray to have clogged stem valves.
Qnasl (beclomethasone dipropionate) Nasal Aerosol, 80 mcg per spray, 120 metered sprays, 8.7 g inhaler, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044; By: 3M Delivery Systems, Northridge, CA 91324, NDC 59310-210-12, UPC 3 59310 21012 9.
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 Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.
Reason Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.
Reason Failed Content Uniformity Specifications: out of specification test result for spray content uniformity.
Reason Failed Impurities/Degradation Specifications: out of specification test results for an impurity during stability testing.
Reason Defective Delivery System; defective valve
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