FDA recall D-0171-2017

Product

Qnasl (beclomethasone dipropionate) Nasal Aerosol 80 Mcg, 50 Metered Sprays, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044, By: 3M Drug Delivery Systems, Northridge, CA 91324, NDC 59310-210-13.

Reason for recall

Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-11-01

Report date

2016-12-14

Termination date

2018-02-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Wales, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0171-2017