Product Detail

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

Recall Number D-556-2013

Classification Class II

Code Info All Lots

Product Distributed Qty 12 vials of 4mL, 1 vial of 6 mL, 1 vial of 8 mLand 3 vials of 10mL

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