Sucralfate Oral Suspension Recalled Due to Microbial Contamination

FDA announced on Sept. 22, 2023 that VistaPharma is voluntarily recalling one lot of Sucralfate Oral Suspension, 1g/10mL, because of contamination of the product by Bacillus cereus. The product, which is used as an antiulcer therapeutic and distributed nationwide, is packaged in a 16 oz (414 mL) polyethylene terephthalate bottle with NDC 66689-305-16. The recalled lot is number 810300 with an expiration date of Oct. 31, 2023.

Microbial contamination of the oral suspension may result in life-threatening infections, such as endocarditis and necrotizing soft tissue infections, according to a press release. As of the time of the press release, the company had not received any reports of adverse events. Adverse events may be reported to FDA via the agency’s MedWatch Adverse Event Reporting program.

The recall is being undertaken by a contractor, Inman, which is notifying distributors and arranging for the return of recalled product.

Source: FDA