Product Detail

Product Description Baclofen 1,000 mcg/mL Injectable, 20 mL and 40 mL vial,
Compounded by The Compounding Shop, St. Petersburg, FL

Recall Number D-551-2013

Classification Class II

Code Info All Lots

Product Distributed Qty 1 vial of 20mL and 1 vial of 40mL

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