The US health regulator classified both the recalls as class III. Withdrawals, & Metformin Hydrochloride extended-release tablet is a prescription oral medication indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type-2 diabetes mellitus. Various companies across the globe have announced similar recalls for the product after the USFDA pointed out presence of NDMA above permissible limits. Since July, recalls involving multiple companies and products have been announced, due to the presence of NDMA in active pharmaceutical ingredient (API) supplied by manufacturer Zhejiang Huahai Pharmaceutical Co Ltd, in Linhai, Taizhou Zhejiang, China. Aurobindo Pharma distributed the drugs nationwide and will be notifying all of its distributors about the recall. AurobindoPharma USA, Inc. contact 1-866-850-2876 Option 2. While Marksans Pharma is recalling diabetes drug, Zydus Pharmaceuticals (USA) is recalling drug which is used to reduce stomach acid. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The voluntary recall of Amlodipine Valsartan tablets USP, Valsartan HCTZ tablets USP and Valsartan tablets USP to the consumer level is due to the detection of trace amounts of an unexpected impurity found in the finished drug … The US Food and Drug Administration (FDA) said on Thursday it has recommended five pharmaceutical firms to voluntarily recall their diabetes drug … Similarly,Aurobindo Pharma (USA) is recalling pain relieving drug, while Jubilant Cadista is recalling a medication used to treat schizophrenia. Similarly, Aurobindo Pharma (USA) is recalling pain-relieving drug, while Jubilant Cadista is recalling a medication used to treat schizophrenia. As per the USFDA, Marksans Pharma is recalling close to six lakh bottles of diabetes drug Metformin Hydrochloride extended-release tablets in strengths of 500 mg and 750 mg in the US market. Drug Recall List Last Updated: November 2020 Drug Recall Details Contact Date Drug Recall Class* Lansoprazole Delayed-Release Orally Disintegrating Tablets 06838277177 Failed Dissolution Specifications If you have questions about this recall, Zydus Pharmaceuticals, 1-877-993-8779. The company is Aurobindo Pharma USA, Inc, a division of Aurobindo Pharma Limited of India. Patients who have medications included in the recall should not stop taking their medications but should contact their doctors or pharmacists about an alternate treatment. The .gov means it’s official.Federal government websites often end in .gov or .mil. More Recalls, Market Similarly, Aurobindo Pharma (USA) is recalling pain relieving drug, while Jubilant Cadista is recalling a medication used to treat schizophrenia. Similarly,Aurobindo Pharma (USA) is recalling pain relieving drug, while Jubilant Cadista is recalling a medication used to treat schizophrenia. "FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level," it noted. Consumers with medical questions regarding this recall or to report an adverse event can contact Aurobindo Pharma USA, Inc. at: Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. This time it is for the combination pill containing amlodipine plus valsartan. We use cookies to understand how you use our site and to improve user experience. As per the USFDA, Marksans Pharma is recalling close to six lakh bottles of diabetes drug Metformin Hydrochloride extended-release tablets in strengths of 500 mg and 750 mg in the US market. As per the USFDA, the company is recalling the product due to deviation from the current good manufacturing practices (CGMP). Similarly, Aurobindo Pharma (USA) is recalling pain relieving drug, while Jubilant Cadista is recalling a medication used to treat schizophrenia. Mirtazapine tablets are indicated for the treatment of major depressive disorder and are packaged in 500 count bottles. As per the USFDA, Marksans Pharma is recalling close to six lakh bottles of diabetes drug Metformin Hydrochloride extended-release tablets in strengths of 500 mg and 750 mg in the US market. Consumers with medical questions regarding this recall or to report an adverse event can contact Aurobindo Pharma USA, Inc. at: 1-866-850-2876 Option 2 pvg@aurobindousa.com Medications listed here may also be marketed under different names in different countries. FDA's testing has shown elevated levels of NDMA in some extended release (ER) metformin formulation, but not in the immediate release (IR) formulation or in the active pharmaceutical ingredient. Bihar Election Results 2020 - Catch the latest news, views and analysis here, Deccan Herald News now on Telegram - Click here to subscribe, Wood sculptors lost in jungle of uncertainty, Egypt finds treasure trove of over 100 sarcophagi, DH Toon | As Modi 'wave' arrives, Oppn boat sinks. Further, the US health regulator said Aurobindo Pharma USA is recalling 7,440 bottles of Ibuprofen oral suspension drug for labelling error. As per the USFDA, a class II recall is initiated in a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. This includes personalising content and advertising. Aurobindo Receives FDA Approval for Ketorolac Tromethamine Ophthalmic Solution, 0.5%. Before sharing sensitive information, make sure you're on a federal government site. Aurobindo Pharma’s Ketorolac Tromethamine Ophthalmic Solution, 0.5% are an AB-rated generic equivalent to … The Food and Drug Administration has issued another drug recall because of contamination with a probable carcinogen. NDMA contamination was responsible for the recall of heartburn drug … New Delhi, Nov 15 (PTI) Indian drug firms like Marksans Pharma, Aurobindo Pharma, Zydus and Jubilant are recalling products in the US market, as … While Marksans Pharma is recalling diabetes drug,  Zydus Pharmaceuticals (USA) is recalling drug which is used to reduce stomach acid. November 2020 Class II Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug … As per the USFDA, Marksans Pharma is recalling close to six lakh bottles of diabetes drug Metformin Hydrochloride extended-release tablets in strengths of 500 mg and 750 mg in the US market. This combo is prescribed for hypertension and heart failure. A recall of common blood pressure medication losartan has been expanded for a fifth time after manufacturer Torrent Pharmaceuticals found a … The action taken by Aurobindo is the latest recall related to valsartan. The USFDA has classified the initiatives taken by Marksans and Zydus as class II recalls. Company Announcement Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 80 … As per the USFDA, a class III recall is initiated in a "situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences". NDMA has been defined as a probable human carcinogen. Similarly, Aurobindo Pharma (USA) is recalling a pain-relieving drug, while Jubilant Cadista is recalling a medication used to treat schizophrenia. Unexpected levels of sedation in particular can contribute to falls in the elderly or motor vehicle accidents in adults. NDMA is classified as a probable human carcinogen based on results from laboratory tests. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products. Another pharmaceutical company is recalling blood pressure medication after detecting trace amounts of a cancer-causing chemical. Similarly, Aurobindo Pharma (USA) is recalling pain relieving drug, while Jubilant Cadista is recalling a medication used to treat schizophrenia. Drugs Associated with Aurobindo Pharma Limited. By continuing to use our site, you accept our use of cookies, revised Privacy Policy. The recalled lots will be returned to the manufacturer. The site is secure. Taking a higher dose than expected, may increase risk of sedation, agitation, increased reflexes, tremor, sweating, dilated pupils, gastrointestinal distress, nausea, constipation and more. Consumers with questions regarding this recall can contact Aurobindo Pharma USA Pharmacovigilance group at (732) 839-9400 Option 2. Aurobindo Pharma USA, Inc. is voluntarily recalling lot number 03119002A3 of Mirtazapine Tablets to the consumer level. Aurobindo Pharma USA, Inc. is notifying its distributors by letter and is arranging for return of all of the recalled product. According to the US FDA enforcement report, the Zolpidem batch was recalled because of “adulterated presence of foreign tablets”. Distributors/retailers that have product which is being recalled should return the bottle(s) to place of purchase. The recalled lot has been produced by Roorkee-based (Uttarakhand) Jubilant Generics. 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