Recall: D-0018-2023

Class II - Potentially Harmful

Class IIClassification

2022-09-30Initiated

TerminatedStatus

VistaPharm, Inc.Firm

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

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

Distribution

USA Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.