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
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