Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Content Uniformity Specifications: out of specification test result for spray content uniformity.
Children's Qnasl 40 mcg (beclomethasone dipropionate) Nasal Aerosol, 40 mcg per spray, 60 Metered Sprays per canister, 4.9g Net Contents, Rx only; Professional Sample; Manufactured for Teva Respiratory, LLC, Horsham, PA 19044; By: 3M Drug Delivery Systems, Northridge, CA 91324; NDC 59310-206-08.
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 Impurities/Degradation Specifications: out of specification test results for an impurity during stability testing.
Reason Defective Delivery System; defective valve
Reason Failed Impurity/Degradation Specification; for 17-BMP at the 9 and 18 month stability time point
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