FDA recall D-1149-2023

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 for recall

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

Distribution

Distributed nationwide to 68 consignees in the U.S.

Key facts

Status

Terminated

Initiation date

2023-08-30

Report date

2023-09-20

Termination date

2024-07-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Largo, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1149-2023