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Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx Only, Ma...

FDA Recall #D-1149-2023 — Class II — August 30, 2023

Recall #D-1149-2023 Date: August 30, 2023 Classification: Class II Status: Terminated

Product Description

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

Reason for Recall

Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results

Recalling Firm

VistaPharm LLC — Largo, FL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

14,400 bottles

Distribution

Distributed nationwide to 68 consignees in the U.S.

Code Information

Lot #: 921100; Exp. 02/2025

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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