Safety Report: VistaPharm Sucralfate Oral Suspension 1g/10mL - recalled due to Potential Bacillus cereus, USA

United States

VistaPharm LLC is voluntarily recalling one (1) lot of Sucralfate Oral Suspension, 1g/10mL, to the consumer level, due to Bacillus cereus contamination in the product. This product was distributed Nationwide to three (3) distributors by wholesale. To date, VistaPharm LLC has not received any reports of adverse events related to this recall.

Risk Statement:  In the population most at risk, the immunocompromised population, there is a reasonable probability that microbial contamination of the oral suspension can result in disseminated, life threatening infections such as endocarditis and necrotizing soft tissue infections.

The product is Sucralfate Oral Suspension 1g/10m, used as an antiulcer therapeutic, and is packaged in a 16oz (414mL) PET Bottle with NDC 66689-305-16. The lot is 810300 with an expiration Date of October 31, 2023. The product can be identified with its product name Sucralfate Oral Suspension 1g per 10mL, with the product Lot No and expiration date, at the bottom right side of the label.

A Contractor, Inmar, will perform this recall process, which is notifying its distributors by recall packet delivered by FEDEX Next Day Delivery and will receive an email notification as well. In addition, Inmar is arranging for the return of all recalled products. Distributors that have any bottles remaining from Sucralfate Oral Suspension Lot 810300, which is being recalled, should return to Inmar via instructions provided.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Potential contamination with Bacillus cereus
Brand name: VistaPharm
Product recalled: Sucralfate Oral Suspension 1g/10mL
Reason of the recall: Potential contamination with Bacillus cereus
FDA Recall date: September 22, 2023

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/vistapharm-llc-issues-voluntary-nationwide-recall-sucralfate-oral-suspension-1g10ml-due-microbial