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 5931
FDA recall notice · announced June 3, 2015 · Teva Pharmaceuticals
Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.
The 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.
Notes
Distribution: Nationwide and Peurto Rico
Lot/code information: Lot #s:130449, 130450; Exp. Date: 12/2015
Quantity: 233,364 Inhalers
Status: Terminated
Products in this recall event:
- 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. mf (D-1087-2015)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.