Antiulcer Medication Under Class I Recall

Microbial contamination with Bacillus cereus has prompted a Class I recall of 180 bottles of sucralfate oral suspension, according to the October 25, 2023, US Food and Drug Administration (FDA) Enforcement Report. The FDA’s most significant recall classification, a Class I designation warns used of the affected drug could cause serious adverse health consequences or death.

“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,” recalling firm VistaPharm announced in a September 22, 2023, statement. “To date, VistaPharm LLC has not received any reports of adverse events related to this recall.”

The recall affects sucralfate oral suspension, 1 g per 10 mL, packaged in 16-ounce bottles (NDC 66689-305-16), from lot 810300 (Exp. 10/31/23). The drug was manufactured and sent to three distributors nationwide by VistaPharm, Largo, Florida.

VistaPharm voluntarily initiated the recall September 15, 2023. On October 16, 2023, the FDA issued its Class I designation.

Sucralfate oral suspension is a prescription drug indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer.