Amerigen Pharmaceuticals Inc. is recalling approximately 5,768 bottles of Temozolomide (5 mg) capsules, a prescription chemotherapy medication, because the product failed dissolution specifications. This defect means the capsules may not break down correctly in the body, which could prevent a patient from receiving the full dose of their medication. The recall affects 5-count and 14-count bottles distributed to wholesalers and retailers across the United States. Consumers should contact their healthcare provider or pharmacist immediately to discuss their treatment options.
When a drug fails dissolution specifications, the medication may not be properly absorbed by the body. This can lead to a lower-than-intended dose of the chemotherapy, which may reduce the effectiveness of the treatment for the patient.
Healthcare guidance and product refund
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Sources: FDA iRES ยท Raw API Response
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