VistaPharm LLC: Drug Recall

Recall #D-0047-2024 · 10/18/2023

Class I: Dangerous

Recall Details

Recall Number: D-0047-2024
Classification: Class I
Product Type: Drug
Recalling Firm: VistaPharm LLC
Status: Terminated
Date Initiated: 10/18/2023
Location: Largo, FL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 180 bottles

Reason for Recall

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

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

Distribution Pattern

USA Nationwide

Other Recalls by VistaPharm LLC

Class III: Low Risk 10/26/2023

Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
Class III: Low Risk 10/17/2023

Failed Excipient Specifications: high content of ethylene glycol (EG)
Class II: Risk 08/30/2023

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

View all recalls by VistaPharm LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.