August 2023 FDA Recall Sucralfate by Vistapharm Llc
D-1149-2023 - Superpotent/Subpotent single ingredient Drug

This Class II drug recall was voluntarily initiated by Vistapharm Llc on August 30, 2023 for the product Sucralfate. The FDA reported the reason for recall as superpotent/subpotent single ingredient drug. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1149-2023

Reason for Recall
Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results
Initiated
08-30-2023
Reported
09-20-2023
Quantity
14,400 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92916
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 LLC
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.
Distributed nationwide to 68 consignees in the U.S.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-26-2024
Product Description About Product Description
Full technical description of the product.
Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx Only, Manufactured and Distributed by: VistaPharm, Inc. Largo, FL 33771, NDC 66689-305-16

Batch or Lot Expiration Information

Lot# : 921100; Exp. 02/2025

Affected Packages Involved in this Recall

66689-305-16 Sucralfate