Sucralfate Oral Suspension recalled over sterility concerns

Recall date

October 18, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

VistaPharm LLC recalls Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles per case), Rx Only, Manufactured and Dis…

Recall number

D-0047-2024

FDA classification

Class I

Brand / firm

VistaPharm LLC

Sold / distributed

USA Nationwide

Why it was recalled

Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles per case), Rx Only, Manufactured and Distributed by: VistaPharm, Inc. Largo, FL 33771 USA, NDC 66689-305-16