Pyridostigmine Bromide Solution
FDA Recall NDC 66689-406
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Pyridostigmine Bromide (NDC 66689-406). A significant event, classified as Class II, was initiated on Sep 30, 2022 by Vistapharm, Llc. The reported reason for this action was: "cGMP Deviations: Out of specification for assay of one of the preservative ingredients."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
cGMP Deviations: Out of specification for assay of one of the preservative ingredients.
Sep 30, 2022
Nov 02, 2022
1980 cups
Recall Profile & Regulatory Data
Event ID
90943
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
VistaPharm, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Termination Date
Apr 30, 2024
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
Batch or Lot Expiration Information
Lot# : 832400, Exp 08/2023
Affected Packages Involved in this Recall
66689-406-01Product
66689-406-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
