Novartis Pharmaceuticals Corporation is recalling approximately 6,997 bottles of Sandimmune Oral Solution (cyclosporine oral solution, USP) 100 mg/mL because the medication was found to contain crystals. The recall affects 50 mL bottles of the prescription drug used to prevent organ rejection in transplant patients. If crystals have formed in the solution, the patient may not receive the correct amount of medication, which can lead to serious health consequences. Consumers using this product should contact their healthcare provider or pharmacist immediately for guidance.
Crystallization in the oral solution can result in an inconsistent concentration of the active ingredient, cyclosporine. This leads to improper dosing, which may cause the medication to be less effective at preventing organ rejection or cause toxic side effects.
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Distributed by Novartis Pharmaceuticals Corporation; Manufactured by DELPHARM Huningue S.A.S.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · FDA Press Release · Raw API Response
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