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U.S. Department of Health and Human Services

Enforcement Report - Week of June 12, 2013

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Product Detail

Product Description Tri-Mix Injections in 5 mL and 10 mL vials (Alprostadil, Phentolamine and Papaverine), compounded by The Compounding Shop, St. Petersburg, FL
Recall Number D-572-2013
Classification Class II
Code Info All Lots
Product Distributed Qty 4 vials of 5mL and 22 vials of 10mL
Reason For Recall Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Event Detail

Event Id 65125
Product Type Drugs
Status Ongoing
Recalling Firm THE COMPOUNDING SHOP, INC.
City St Petersburg
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-02
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Florida, California, Minnesota, and Maine
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