September 2022 FDA Recall Pyridostigmine Bromide by Vistapharm, Inc.
D-0018-2023 - cGMP Deviations

This Class II drug recall was voluntarily initiated by Vistapharm, Inc. on September 30, 2022 for the product Pyridostigmine Bromide. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0018-2023

Reason for Recall
cGMP Deviations: Out of specification for assay of one of the preservative ingredients.
Initiated
09-30-2022
Reported
11-02-2022
Quantity
1980 cups

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90943
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
VistaPharm, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-30-2024
Product Description About Product Description
Full technical description of 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

Batch or Lot Expiration Information

Lot# : 832400, Exp 08/2023

Affected Packages Involved in this Recall

66689-406-01 Pyridostigmine Bromide
66689-406-10 Pyridostigmine Bromide