Methotrexate 25mg/mL Injectable, 10 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL

Recall Number: D-548-2013

Firm: THE COMPOUNDING SHOP, INC.

Classification: Class II

Status: Terminated

Report Date: 20130612

Initiation Date: 20130502

Termination Date: 20240930

Reason for Recall

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Product Description

Methotrexate 25mg/mL Injectable, 10 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL