Aurobindo Pharma Limited has initiated a nationwide recall of three drugs from the US, two of them due to manufacturing issues. The development comes close on the heels of the regulatory compliance issues being faced by several of its manufacturing facilities back home.
These three products include heartburn drug Ranitidine that the US Food and Drug Administration(US FDA) had recently asked the companies to withdraw from the market owing to the presence of carcinogenic nitrosodimethylamine (NDMA) compound above the daily acceptable intake limits in the formulation.
The recall of ranitidine was in different dosages of tablets and capsules of 30-500 count bottles, totalling 276,048 bottles besides 19,320 bottles of Ranitidine syrup, according the FDA.
The company has also initiated a voluntary recall of 197,000 vials of Amiodarone Hydrochloride injection, which is used in treating irregular heartbeat in patients, and 112,00 vials of local anesthetic Lidocaine HCL injection belonging to specific batches. All three drugs were distributed by Aurobindo Pharma’s US subsidiary AuroMedics Pharma LLC. Aurobindo started recalling the formulations in the first and the second weeks of November.
The action on Ranitidine and Lidocaine, defined as a Class-II recall, was taken due to the presence of foreign and potentially harmful material in the drug that could cause temporary or medically reversible adverse health consequences. In the case of Amiodarone, the company has initiated a class III recall after the visible presence of particulate matter in the vials due to crystallisation, though the product is unlikely to have any adverse health impact.
In April, the US FDA said it had asked the companies to recall the heartburn drug from the market as the formulation was found to contain carcinogenic material. Last month, several companies including Dr Reddy’s and GSK had recalled their Ranitidine generics from the US market.
In recent times the generic drug firms had to face two industry-level recalls, the first involving the blood pressure-lowering drug sartans, followed by ranitidine, due to the presence of carcinogens in the active ingredients of the respective medicines.-Business Standard