Recall: D-1149-2023

Class II - Potentially Harmful

Class IIClassification

2023-08-30Initiated

TerminatedStatus

VistaPharm LLCFirm

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

Reason

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

Distribution

Distributed nationwide to 68 consignees in the U.S.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.