FDA recall D-382-2014

Teva Pharmaceuticals USA · Class III · drug

Product

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.

Reason for recall

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.

Distribution

Nationwide and Puerto Rico

Key facts

Status
Terminated
Initiation date
2013-12-04
Report date
2014-01-01
Termination date
2014-08-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Horsham, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-382-2014