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

FDA recall notice · announced November 2, 2022 · Vistapharm

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: USA Nationwide
Lot/code information: Lot#: 832400, Exp 08/2023
Quantity: 1980 cups
Status: Terminated
Products in this recall event:
- 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 (D-0018-2023)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.