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This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which has been found in the recalled products. However, not all products containing valsartan are recalled.
NDMA is classified as a probable carcinogen to humans – a substance that can cause cancer – based on laboratory test results. The presence of NDMA is thought to be related to changes in the way the active substance has been manufactured.
"The FDA is committed to maintaining our standard of excellence in safety and effectiveness, including our efforts to ensure the quality of drugs." When we identify failures in the quality of drugs and manufacturing issues that can potentially create risks for patients, we pledge to take prompt action, "said FDA Commissioner Scott Gottlieb, MD."
– Since valsartan is prescribed in drugs for the treatment of serious illnesses, patients taking the recalled valsartan medications should continue to take their medications until they have taken medication.
– To determine if a specific product has been recalled, patients should consult the name of the drug and the name of the company on the label of their prescription b Bottle If the information is not on the bottle, patients should contact the pharmacy that administered the medication.
– If a patient takes one of the recalled medications, he must follow the recall instructions provided by the company in question. This information has been published on the FDA website
– Patients should also contact their healthcare professional (the pharmacist who prescribed the drug or the doctor who prescribes the medicine) if their drug is included in this reminder to discuss their treatment, which may include another valsartan product not affected by this recall or other treatment option.
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