FDA recall D-1453-2016

Teva North America · Class III · drug

Product

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.

Reason for recall

Failed Content Uniformity Specifications: out of specification test result for spray content uniformity.

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2016-07-15
Report date
2016-08-10
Termination date
2017-03-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Horsham, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1453-2016