Pharmakon Pharmaceuticals recalls Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.25 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, R…

Recall date

August 19, 2015

Source

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

Recall number

D-0608-2016

FDA classification

Class II

Brand / firm

Pharmakon Pharmaceuticals

Sold / distributed

Nationwide

Why it was recalled

Stability data does not support expiry.

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 Set II in 0.9% Sodium Chloride, 0.25 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.