PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: October 25, 2023 Initiated: October 18, 2023 #D-0047-2024

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

Reason for Recall

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

Details

Recalling Firm
VistaPharm LLC
Units Affected
180 bottles
Distribution
USA Nationwide
Location
Largo, FL

Frequently Asked Questions

What product was recalled?
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. Recalled by VistaPharm LLC. Units affected: 180 bottles.
Why was this product recalled?
Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 25, 2023. Severity: Critical. Recall number: D-0047-2024.