SIU-Prostaglandin E1 500 mcg/mL Injection recalled over sterility concerns

Recall date

June 26, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

The Apothecary Shoppe LLC recalls SIU-Prostaglandin E1 500 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135

Recall number

D-1313-2015

FDA classification

Class II

Brand / firm

The Apothecary Shoppe LLC

Sold / distributed

Oklahoma

Why it was recalled

Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

SIU-Prostaglandin E1 500 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135