Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in 5mL unit-dose cup...
FDA Recall #D-0018-2023 — Class II — September 30, 2022
Product Description
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.
Recalling Firm
VistaPharm, Inc. — Largo, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1980 cups
Distribution
USA Nationwide
Code Information
Lot#: 832400, Exp 08/2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated