Class III · Low risk Terminated
Qnasl
Reason Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.
Children's Qnasl 40 mcg
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Content Uniformity Specifications: out of specification test result for spray content uniformity.
What was recalled
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.
- Recalling firm
- Teva North America
- NDC code
- 59310-206-08
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1453-2016
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.
Other Beclomethasone recalls
See all
Class III · Low risk Terminated
Qnasl
Reason Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.
Class III · Low risk Terminated
Qvar
Reason Failed Impurities/Degradation Specifications: out of specification test results for an impurity during stability testing.
Class II · Moderate risk Terminated
Qvar¿
Reason Defective Delivery System; defective valve
Class III · Low risk Terminated
Qvar¿
Reason Failed Impurity/Degradation Specification; for 17-BMP at the 9 and 18 month stability time point
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