Teva Pharmaceuticals USA recalls QVAR (beclomethasone dipropionate HFA 40 mcg), 40 mcg Inhalation Aerosol, For Oral Inhalation with QVAR Actuator Only,…

Recall date

May 7, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1087-2015

FDA classification

Class III

Brand / firm

Teva Pharmaceuticals USA

Sold / distributed

Nationwide and Peurto Rico

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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