Drug product
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
D-1149-2023
Product summary
- Firm
- VistaPharm LLC
- Event
- Event 92916
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14,400 bottles
- Official record key
drug-enforcement:D-1149-2023
Official wording
Reason: Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results
Code information: Lot #: 921100; Exp. 02/2025
Distribution pattern: Distributed nationwide to 68 consignees in the U.S.
Derived failure modes
-
Potency or specification failure
Superpotent