Drug Recall: In Largo, Florida, VistaPharm LLC is voluntarily recalling one (1) lot of Sucralfate Oral Suspension, 1 g/10 mL, to the consumer level due to Bacillus cereus contamination in the product.
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.
To date, VistaPharm LLC has not received any reports of adverse events related to this recall.
The product is used as an antiulcer therapeutic and is packaged in a 16-ounce (414-mL) PET bottle with NDC 66689-305-16.
The affected Sucralfate Oral Suspension lot is number 810300, with an expiration date of October 31, 2023.
The product can be identified by its product name, Sucralfate Oral Suspension 1g per 10 mL, which is Lot No. 810300, with an expiration date of October 31, 2023, at the bottom right side of the label.
This sucralfate oral suspension lot was distributed nationwide to three (3) distributors by wholesale.
A contractor, Inmar, will perform this recall process, which involves notifying its distributors by recall packet delivered by FEDEX Next Day Delivery and receiving 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 the instructions provided.
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