Hydroxyprogesterone 250 mg/mL Injectable, 4 mL, 6 mL,8 mL and 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

Recall Number: D-556-2013

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

Hydroxyprogesterone 250 mg/mL Injectable, 4 mL, 6 mL,8 mL and 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL