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U.S. Department of Health and Human Services

Enforcement Report - Week of May 28, 2014

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Product Detail

Product Description QVAR® (beclomethasone dipropionate HFA), 80mcg Inhalation Aerosol, 50 metered inhalations/120 metered inhalations, packaged in an aluminum cylinder, Mktd. by: Teva Respiratory, LLC, Horsham, PA, Mfd. by: 3M Drug Delivery Systems, Northridge, CA.
Recall Number D-1341-2014
Classification Class II
Code Info 130140 11/2014 59310-204-85 80 mcg 4.2g / 50 metered inhalations 130143 3/2015 59310-204-80 80 mcg 8.7g / 120 metered inhalations 130144 3/2015 59310-204-80 80 mcg 8.7g / 120 metered inhalations
Product Distributed Qty 461,592 canisters
Reason For Recall Defective Delivery System; defective valve

Event Detail

Event Id 68121
Product Type Drugs
Status Ongoing
Recalling Firm Teva Pharmaceuticals USA
City Horsham
State PA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-04-23
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide
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