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
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