Product Detail

Product Description Baclofen/Bupivacaine 2,000 mcg/20 mg/mL Injectable, 45 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL

Recall Number D-552-2013

Classification Class II

Code Info All Lots

Product Distributed Qty 3 vials of 45mL

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