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Potential Contamination Leads to Recall of VistaPharm’s Sucralfate
In patients who are immunocompromised, Bacillus cereus can result in life-threatening infections such as endocarditis and necrotizing soft tissue infections.
VistaPharm is recalling one lot of Sucralfate Oral Suspension, 1g/10mL, which is used to treat patients with duodenal ulcers, because of Bacillus cereus contamination in the product. Bacillus cereus is a Gram-positive bacteria found in food and cause food poisoning. But in patients who are immunocompromised, Bacillus cereus can result in life-threatening infections such as endocarditis and necrotizing soft tissue infections.
VistaPharm has not received any reports of adverse events. A contractor, Inmar, is conducting the recall.
The affected lot, 810300, has an expiration date of Oct. 31, 2023, and NDC number 66689-305-16.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
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FDA Approves Stelara Biosimilar, Selarsdi
April 18th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
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