D-0047-2024 Class I Terminated

Recalled by VistaPharm LLC — Largo, FL

FDA drug recall D-0047-2024 was initiated by VistaPharm LLC on Oct 18, 2023 and is designated Class I. Reason for recall: Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus. The recall status is terminated (terminated Apr 30, 2024). Affected quantity: 180 bottles.

Recall Details

Product Type
Drugs
Report Date
Oct 25, 2023
Initiation Date
Oct 18, 2023
Termination Date
Apr 30, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
180 bottles

Product Description

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

Reason for Recall

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

Distribution Pattern

USA Nationwide

Code Information

Lot#: 810300, Exp 10/2023

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-0047-2024
openFDA file date
Nov 3, 2026
Loaded by RegDataLab
Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Source: openFDA record for D-0047-2024. Report a data issue: hello@regdatalab.com.