Drug Enforcement D-1149-2023

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

Status

Terminated

Classification

Class II

Report Date

September 20, 2023

Termination Date

July 26, 2024

Product Information

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
Product quantity
14,400 bottles
Reason for recall
Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Distributed nationwide to 68 consignees in the U.S.

Location & Firm

Recalling firm
VistaPharm LLC
Address
7265 Ulmerton Rd

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-1149-2023
Event ID
92916
Recall initiation date
August 30, 2023
Center classification date
September 11, 2023
Code info
Lot #: 921100; Exp. 02/2025
More code info
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