Dr Reddy's, Aurobindo recall drugs from US market
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.
According to a notification issued by the US Food and Drug Authority, Dr Reddy's is recalling Olanzapine tablets USP of 2.5 mg while Aurobindo is recalling Pantoprazole Sodium for Injection, 40mg per vial from the market.
Both the recalls are voluntarily initiated by respective companies, the FDA said.
Dr Reddy's is recalling 5,904 bottles of Olanzapine 30-count bottles from the market. Aurobindo is recalling Pantoprazole Sodium for Injection, 40mg per vial, single-dose of 29,800 vials under Class-III classification.
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."
"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 DRL's recall.
"Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance," the drug health regulator said in case of Aurobindo.
Olanzapine tablets are used for: Treating schizophrenia or bipolar disorder and Pantoprazole sodium for injection is indicated for short-term treatment (7 to 10 days) of adult patients with gastroesophageal reflux disease (GERD) and a history of erosive esophagitis.
According to a notification issued by the US Food and Drug Authority, Dr Reddy's is recalling Olanzapine tablets USP of 2.5 mg while Aurobindo is recalling Pantoprazole Sodium for Injection, 40mg per vial from the market.
Both the recalls are voluntarily initiated by respective companies, the FDA said.
Dr Reddy's is recalling 5,904 bottles of Olanzapine 30-count bottles from the market. Aurobindo is recalling Pantoprazole Sodium for Injection, 40mg per vial, single-dose of 29,800 vials under Class-III classification.
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."
"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 DRL's recall.
"Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance," the drug health regulator said in case of Aurobindo.
Olanzapine tablets are used for: Treating schizophrenia or bipolar disorder and Pantoprazole sodium for injection is indicated for short-term treatment (7 to 10 days) of adult patients with gastroesophageal reflux disease (GERD) and a history of erosive esophagitis.
