US Drug Recall Register
Class II · Moderate risk Terminated Initiated May 2, 2013 (13 years ago)

Hydroxyprogesterone 250 mg/mL Injectable, 4 mL, 6 mL,8 mL and 10 mL vials, compounded by…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

What was recalled

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

Recalling firm
The Compounding Shop, INC.
Origin
FL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-556-2013

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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