TOPIC: Sucralfate Oral Suspension, 1g/10mL by VistaPharm: Recall - Due to Microbial Contamination Identified as Bacillus cereus
AUDIENCE: Patient, Health Professional, Gastroenterology
ISSUE: VistaPharm is recalling one (1) lot of Sucralfate Oral Suspension, 1g/10mL due to Bacillus cereus contamination in the product, it is packaged in a 16oz (414mL) 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 with its product name Sucralfate Oral Suspension 1g per 10mL, with the product Lot No 810300 and expiration date of October 31, 2023, at the bottom right side of label. This Sucralfate Oral Suspension Lot was distributed Nationwide to three (3) distributors by wholesale.
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.
To date, VistaPharm has not received any reports of adverse events related to this recall.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: The product is used as an antiulcer therapeutic.
RECOMMENDATIONS:
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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.
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Distributors that have any bottles remaining from Sucralfate Oral Suspension Lot 810300, which is being recalled, should return to Inmar via instructions provided.
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Consumers with questions regarding this recall can contact the company.
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