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A pharmaceutical company is expanding the recall of certain tablets for the treatment of high blood pressure after the discovery of the active ingredient in the active ingredient, the US Food and Drug Administration announced.
The FDA has indicated that the recall would be extended to a further 36 batches of Losartan Potassium Tablets USP and 68 batches of Losartan Potassium and Hydrochlorothiazide Tablets, USP.
The detected impurity is N-methylnitrosobutyric acid (NMBA), potentially carcinogenic to humans.
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Here are the complete details of the FDA:
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Update: Torrent Pharmaceuticals Limited Extends Voluntary National Booster of Losartan Potassium, Losartan Potassium / Hydrochlorothiazide Tablets, USP, USP
Torrent Pharmaceuticals Limited expands the recall of Losartan Potassium Tablets USP and Losartan Potassium / Hydrochlorothiazide Tablets, USP, to consumers due to the detection of traces of an unexpected impurity found in an active pharmaceutical ingredient manufactured by Hetero Labs Limited . .
The recall is expanded to include a further 36 batches of Losartan Potassium Tablets USP and 68 batches of Losartan Potassium and Hydrochlorothiazide Tablets, USP
The impurity detected in the API is N-methylnitrosobutyric acid (NMBA). Torrent only recalls batches of products containing losartan containing N-methylnitrosobutyric acid (NMBA) above the acceptable daily intake levels published by the FDA.
To date, Torrent Pharmaceuticals Limited has not received any reports of adverse events related to this recall.
Losartan is used to treat hypertension, hypertensive patients with left ventricular hypertrophy and treatment of nephropathy in patients with type 2 diabetes. Losartan Potassium and hydrochlorothiazide tablets, USP are used to treat hypertension and hypertensive patients with left ventricular hypertrophy.
Patients taking Losartan Potassium Tablets, USP and Losartan Potassium / Hydrochlorothiazide Tablets, USP should continue taking their medications because the risk of harm to the patient's health may be higher if the treatment is stopped immediately without further treatment. Patients should contact their pharmacist or their treating physician, who can inform them of an alternative treatment before returning their medication.
The products / lots included in the extended recall are listed below in red. The product can be identified by verifying the product name, the manufacturer's details and the lot or lot number on the bottle containing these products.
Torrent Pharmaceuticals Limited expands the recall of Losartan Potassium Tablets USP and Losartan Potassium / Hydrochlorothiazide Tablets, USP, to consumers due to the detection of traces of an unexpected impurity found in an active pharmaceutical ingredient manufactured by Hetero Labs Limited . .
Losartan Potassium Tablets, USP and Losartan Potassium / Hydrochlorothiazide Tablets, USP have been distributed nationally to wholesale distributors, repackaging companies and retailers in Torrent. Torrent Pharmaceuticals Limited advises its distributors and customers by telephone and in writing to immediately stop the distribution of the specific lots recalled and to notify their sub-accounts. Torrent organizes the return of all recalled products to Qualanex. The instructions for returning the recalled products are given in the reminder letter.
DETAILS AND PHOTOS OF PRODUCT
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