On September 22, 2023, the U.S. Food and Drug Administration (FDA) announced VistaPharm LLC’s voluntary recall of one lot of sucralfate oral suspension, 1g/10 ml, to the consumer level, because of Bacillus cereus contamination in the product.
VistaPharm said that there is a reasonable probability that microbial contamination of the oral suspension could result in disseminated, life-threatening infections (e.g., endocarditis, necrotizing soft tissue infections) in immunocompromised patients at highest risk. However, to date VistaPharm LLC has not received any reports of adverse events related to the recall. The company said that the recall is being conducted under FDA’s knowledge.
The product is used as an antiulcer therapeutic and is packaged in a 16 oz (414 ml) PET bottle printed with NDC 66689-305-16. The affected lot is number 810300 with an expiration date of October 31, 2023. The product can be identified with its product name, “Sucralfate Oral Suspension 1 g per 10 ml,” along with the lot number and expiration date at the bottom right side of label. The was distributed nationwide to three distributors by wholesale.
Inmar, the contractor for the recall process, is sending email notifications and recall packets to distributors by FedEx next day delivery and arranging for the return of all recalled products. Distributors that have any bottles remaining from sucralfate oral suspension lot 81030 should follow the provided instructions to return the product to Inmar.
Consumers with questions regarding the recall can contact Inmar at 800-967-5952 or email email@example.com from 9 am–5 pm ET Monday–Friday.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Healthcare professionals and consumers should report any adverse reactions or quality problems they experienced using the product to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.