Pyridostigmine Bromide Oral Solution recalled over manufacturing violations

Recall date

September 30, 2022

Source

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

Official notice title

VistaPharm, Inc. recalls Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in 5mL unit-dose cup, Rx only, Dist. by: V…

Recall number

D-0018-2023

FDA classification

Class II

Brand / firm

VistaPharm, Inc.

Sold / distributed

USA Nationwide

Why it was recalled

cGMP Deviations: Out of specification for assay of one of the preservative ingredients.

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

What was recalled

Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in 5mL unit-dose cup, Rx only, Dist. by: VistaPharm, NDC 66689-406-01