PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: September 20, 2023 Initiated: August 30, 2023 #D-1149-2023

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

Details

Recalling Firm
VistaPharm LLC
Units Affected
14,400 bottles
Distribution
Distributed nationwide to 68 consignees in the U.S.
Location
Largo, FL

Frequently Asked Questions

What product was recalled?
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. Recalled by VistaPharm LLC. Units affected: 14,400 bottles.
Why was this product recalled?
Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results
Which agency issued this recall?
This recall was issued by the FDA Drug on September 20, 2023. Severity: Moderate. Recall number: D-1149-2023.