D-1149-2023 Class II Terminated
FDA drug recall D-1149-2023 was initiated by VistaPharm LLC on Aug 30, 2023 and is designated Class II. Reason for recall: Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results The recall status is terminated (terminated Jul 26, 2024). Affected quantity: 14,400 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 20, 2023
- Initiation Date
- Aug 30, 2023
- Termination Date
- Jul 26, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,400 bottles
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
Distribution Pattern
Distributed nationwide to 68 consignees in the U.S.
Code Information
Lot #: 921100; Exp. 02/2025
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1149-2023
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026