FDA recall D-0018-2023

Product

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

Reason for recall

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

Distribution

USA Nationwide

Key facts

Status

Terminated

Initiation date

2022-09-30

Report date

2022-11-02

Termination date

2024-04-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Largo, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0018-2023