Sucralfate Suspension
FDA Recall NDC 66689-305
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Sucralfate (NDC 66689-305). A significant event, classified as Class I, was initiated on Oct 18, 2023 by Vistapharm, Llc. The reported reason for this action was: "Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
October 2023 Class I Recall: Microbial Contamination of Non-Sterile Products
Recall Number
Class I Terminated
Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.
Oct 18, 2023
Oct 25, 2023
180 bottles
Recall Profile & Regulatory Data
Event ID
93096
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
VistaPharm LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Termination Date
Apr 30, 2024
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
Batch or Lot Expiration Information
Lot# : 810300, Exp 10/2023
Affected Packages Involved in this Recall
66689-305-16Product
Class II Terminated
Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results
Aug 30, 2023
Sep 20, 2023
14,400 bottles
Recall Profile & Regulatory Data
Event ID
92916
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
VistaPharm LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed nationwide to 68 consignees in the U.S.
Termination Date
Jul 26, 2024
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
Batch or Lot Expiration Information
Lot# : 921100; Exp. 02/2025
Affected Packages Involved in this Recall
66689-305-16Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
