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Best Read Product Recall Stories of 2023
Recall Impacts Exela and Civica Brands
In total, 11 lots of three different products have been recalled because of silicone found in retained samples.
Several Lots of Sandimmune Involved in Two Recall Efforts
Crystal formation observed Sandimmune Oral Solution (cyclosporine), which is used to prevent organ rejection in kidney, liver, and heart allogeneic transplants.
Stability and Purity Issues Lead to Recall of Tydemy
One of the two recalled lots of the birth control tested high for a known impurity.
Subpotency Leads to Recall of 27 Lots of Tirosint-SOL
IBSA Pharma is recalling the hypothyroid medication because analyses showed lowered levels of levothyroxine in some lots.
FDA Warns About Certain Compounded Semaglutide Products
The FDA has received adverse event reports after patients have used compounded semaglutide that contains salt formulations, which are different active ingredients than that used in the agency-approved drugs for diabetes and weight loss.
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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