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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