FDA recall D-1087-2015

Product

QVAR (beclomethasone dipropionate HFA 40 mcg), 40 mcg Inhalation Aerosol, For Oral Inhalation with QVAR Actuator Only, 120 metered inhalations, Rx Only, Mktd by Teva Respiratory, LLC., Horsham, PA. mfd by 3M Drug Delivery Systems, Northridge, CA, NDC 59310-0202-12

Reason for recall

Failed Impurities/Degradation Specifications: out of specification test results for an impurity during stability testing.

Distribution

Nationwide and Peurto Rico

Key facts

Status

Terminated

Initiation date

2015-05-07

Report date

2015-06-03

Termination date

2016-11-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Horsham, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1087-2015