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Class II: temporary or reversible health riskTerminated

VistaPharm Pyridostigmine Bromide Oral Solution Recall

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

VistaPharm, Inc. · Largo, FL

Risk level
Class II
Reported by FDA
Nov 2, 2022
Recall ID
D-0018-2023
Check your lot numberHow we source this data

Summary

VistaPharm recalled Pyridostigmine Bromide Oral Solution starting Sep 30, 2022. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0018-2023 on Nov 2, 2022. Reason: cGMP Deviations: Out of specification for assay of one of the preservative ingredients. Status: Terminated.

Why it was recalled

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

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

Lot numbers, UPCs & expiration codes

Lot#: 832400, Exp 08/2023

Where it was sold

USA Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0018-2023
Classification
Class II
Status
Terminated
Recall initiated
Sep 30, 2022
FDA report date
Nov 2, 2022
Quantity
1980 cups
Recall type
Voluntary: Firm initiated
Recalling firm
VistaPharm, Inc.

Original FDA data

Every field from FDA enforcement report D-0018-2023, exactly as published.

Show all FDA fields
City
Largo
State
FL
Status
Terminated
Country
United States
Event ID
90943
Address
7265 Ulmerton Rd
Code information
Lot#: 832400, Exp 08/2023
Postal code
33771-4809
Report date
Nov 2, 2022
Product type
Drugs
Recall number
D-0018-2023
Classification
Class II
Recalling firm
VistaPharm, Inc.
Product quantity
1980 cups
Termination date
Apr 30, 2024
Reason for recall
cGMP Deviations: Out of specification for assay of one of the preservative ingredients.
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
USA Nationwide
Recall initiation date
Sep 30, 2022
Initial firm notification
Letter
Center classification date
Oct 21, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0018-2023, published Nov 2, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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