FDA recall D-0047-2024

Product

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

Reason for recall

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

Distribution

USA Nationwide

Key facts

Status

Terminated

Initiation date

2023-10-18

Report date

2023-10-25

Termination date

2024-04-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Largo, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0047-2024