Product Detail

Product Description Sodium EDTA 150 mg/mL Injectable, 250 mL vial, compounded by The Compounding Shop, St. Petersburg, FL

Recall Number D-557-2013

Classification Class II

Code Info All Lots

Product Distributed Qty 43 vials of 250mL each

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