Promethazine 25 mg added to 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 Promethazine 25 mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Braun PAB bag, Rx, Only, Compounded by PHARMA…

Recall number

D-1276-2016

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

Promethazine 25 mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Braun PAB bag, Rx, Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0187-41