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

FDA recall notice · announced October 25, 2023 · Vistapharm

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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.

Notes

Distribution: USA Nationwide
Lot/code information: Lot#: 810300, Exp 10/2023
Quantity: 180 bottles
Status: Terminated
Products in this recall event:
- 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 (D-0047-2024)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.