Drug Enforcement D-0047-2024

Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.

Status

Terminated

Classification

Class I

Report Date

October 25, 2023

Termination Date

April 30, 2024

Product Information

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
Product quantity
180 bottles
Reason for recall
Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
USA Nationwide

Location & Firm

Recalling firm
VistaPharm LLC
Address
7265 Ulmerton Rd, N/A

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

Codes & Dates

Recall number
D-0047-2024
Event ID
93096
Recall initiation date
October 18, 2023
Center classification date
October 16, 2023
Code info
Lot#: 810300, Exp 10/2023
More code info
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