FDA-Drug2023-10-25Class I

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

VistaPharm LLC
Hazard

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

Sold states
USA Nationwide
Affected count
180 bottles
Manufactured in
7265 Ulmerton Rd, N/A, Largo, FL, United States
Products
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

Official notice

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

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