Provocholine pre-diluted 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 Provocholine pre-diluted in 0.9% Sodium Chloride Set II syringes, 0.0625mg/mL,3 mL; 0.25 mg/mL 3mL; 1 mg/mL 3mL; 4 mg/m…

Recall number

D-1290-2016

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

Provocholine pre-diluted in 0.9% Sodium Chloride Set II syringes, 0.0625mg/mL,3 mL; 0.25 mg/mL 3mL; 1 mg/mL 3mL; 4 mg/mL 3mL; 16 mg/ml 3mL, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0674-80