Medications & Supplements/Prescription Drugs

VistaPharm Pyridostigmine Bromide Oral Solution Recalled for Potency Issues

Agency Publication Date: October 21, 2022

Summary

VistaPharm, Inc. has recalled one lot of Pyridostigmine Bromide Oral Solution, USP (60 mg/5 mL) because the preservative ingredients in the medication did not meet potency specifications. The recall affects approximately 1,980 unit-dose cups distributed to pharmacies nationwide. No incidents or injuries have been reported to date in connection with this issue.

Risk

Preservatives that are not at the correct strength may fail to prevent the growth of harmful microorganisms or may not maintain the drug's stability over time, potentially impacting the medication's safety and effectiveness.

What You Should Do

This recall affects VistaPharm Pyridostigmine Bromide Oral Solution, USP (60 mg/5 mL) packaged in 5 mL unit-dose cups (NDC 66689-406-01).
Check your medication for Lot 832400 with an expiration date of 08/2023.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact VistaPharm, Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Pyridostigmine Bromide Oral Solution, USP (60 mg/5 mL)by VistaPharm

Variants: 60 mg/5 mL, 5 mL unit-dose cup

Lot Numbers:

832400 (Exp 08/2023)

NDC:

66689-406-01

Distributed by VistaPharm; Recall # D-0018-2023

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90943

Status: Resolved

Manufacturer: VistaPharm, Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 1980 cups

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects VistaPharm Pyridostigmine Bromide Oral Solution, USP (60 mg/5 mL) packaged in 5 mL unit-dose cups (NDC 66689-406-01).

Check your medication for Lot 832400 with an expiration date of 08/2023.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact VistaPharm, Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.