HYDROmorphone HCI 1mg/mL in 0 recalled over sterility concerns

Recall date

April 20, 2016

Source

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

Official notice title

Pharmakon Pharmaceuticals, Inc. recalls HYDROmorphone HCI 1mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless Syringe, Rx Only, Compounde…

Recall number

D-1325-2016

FDA classification

Class II

Brand / firm

Pharmakon Pharmaceuticals, Inc.

Sold / distributed

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

Why it was recalled

Lack of Assurance of Sterility

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

What was recalled

HYDROmorphone HCI 1mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0932-68