Recall: D-0047-2024

Class I - Dangerous

Class IClassification

2023-10-18Initiated

TerminatedStatus

VistaPharm LLCFirm

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

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

Distribution

USA Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.