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U.S. Department of Health and Human Services

Enforcement Report - Week of October 3, 2012

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Event Detail

Event ID 63095
Product Type Drugs
Status Ongoing
Recalling Firm Dispensing Solutions, Inc
City Santa Ana
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-28
Initial Firm Notification of
Consignee or Public
Distribution Pattern US: IN & WI

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Atrovent HFA Inhalation Aerosol, (ipratropium bromide) 12.9 grams, 200 metered actuations, Rx only, Packaged Exclusively by: Dispensing Solutions, Inc., Santa Ana, CA --- NDC 68258-8952-01, DSI product #8A0947 Lot # F23989, F22311 Class II Label Mix up; side panel of sticker label applied by Dispensing Solutions Inc. incorrectly indicates product name as Ventolin HFA 90 mcg instead of correctly as Atrovent HFA 12.9 grams Inhalation Aerosol 18 Inhalers D-1691-2012