کسب درآمد و فروشگاه اینترنتی Both the recalls are voluntarily initiated by respective companies
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دوشنبه 5 ارديبهشت 1401 زمان : 10:37

Both the recalls are voluntarily initiated by respective companies, the FDA said.Hyderabad: Drug firms Dr Reddy’s Laboratories Limited and Aurobindo Pharma Limited have separately started recalling few quantities of two different drugs from the US market as they are found to be not up to the mark. Aurobindo is recalling plastic auto Windshield wiper Mold Pantoprazole Sodium for Injection, 40mg per vial, single-dose of 29,800 vials under Class-III classification. Dr Reddys is recalling 5,904 bottles of Olanzapine 30-count bottles from the market.According to a notification issued by the US Food and Drug Authority, Dr Reddy’s is recalling Olanzapine tablets USP of 2. Olanzapine tablets are used for: Treating schizophrenia or bipolar disorder and Pantoprazole sodium forinjection is indicated for short-term treatment (7 to 10 days) of adult patients with gastroesophageal reflux disease (GERD) and a history of erosive esophagitis.5 mg while Aurobindo is recalling Pantoprazole Sodium for Injection, 40mg per vial from the market."Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance," the drug health regulator said in case of Aurobindo.""Failed impurities/degradation specifications: due to out-of-specification result for the Related Substance Compound C (Impurity 6 - N-Oxide at the 18 month stability station," FDA said as reason for DRLs recall.According to FDA, "Class-III" classification which was described as "a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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