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D-1149-2023Class II

VistaPharm LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
VistaPharm LLC
Product type
Drug
Status
Terminated
Report date
2023-09-20
Distribution
Distributed nationwide to 68 consignees in the U.S.
Firm state
FL
Product quantity
14,400 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

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

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

Code / lot info

Lot #: 921100; Exp. 02/2025

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →