US Drug Recall Register
Class II · Moderate risk Terminated Initiated Sep 30, 2022 (4 years ago)

Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in 5mL…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

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

Recalling firm
VistaPharm, Inc.
NDC code
66689-406-01
Origin
FL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0018-2023

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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