FDA-Drug2023-09-20Class II

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

VistaPharm LLC
Hazard

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

Sold states
Distributed nationwide to 68 consignees in the U.S.
Affected count
14,400 bottles
Manufactured in
7265 Ulmerton Rd, Largo, FL, United States
Products
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

Official notice

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

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