PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: June 3, 2015 Initiated: May 7, 2015 #D-1087-2015

Product Description

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.

Details

Recalling Firm
Teva Pharmaceuticals USA
Units Affected
233,364 Inhalers
Distribution
Nationwide and Peurto Rico
Location
Horsham, PA

Frequently Asked Questions

What product 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. Recalled by Teva Pharmaceuticals USA. Units affected: 233,364 Inhalers.
Why was this product recalled?
Failed Impurities/Degradation Specifications: out of specification test results for an impurity during stability testing.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 3, 2015. Severity: Low. Recall number: D-1087-2015.