Recalling firm
VistaPharm LLC
Product type
Drug
Status
Terminated
Report date
2023-09-20
Distribution
Distributed nationwide to 68 consignees in the U.S.
Firm state
FL
Product quantity
14,400 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results
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
Code / lot info
Lot #: 921100; Exp. 02/2025
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.