Chemotherapy Drug Recalled over Lack of Sterility Assurance
According to the Economic Times, Sun Pharmaceuticals Ltd. is recalling 200 vials of the chemotherapy drug gemcitabine in the United States due to a lack of assurance of sterility.
The U.S. Food and Drug Administration (FDA) announced the recall last week. Sun Pharma’s unit Caraco Pharmaceutical Laboratories Ltd. reportedly manufactured the drugs at its plant in Gujarat, India.
The recall is voluntary and was classified by the FDA as a Class II, meaning that use of or exposure to the recalled drug may cause temporary or medically reversible adverse health consequences.
Reuters reported that this is the pharmacy’s second major drug recall recently, as earlier this year it recalled about 2,528 bottles of its generic version of diabetes drug Glumetza after it received a customer complaint that one of the bottles contained tablets of an epilepsy drug.
What Can I Do If a Chemotherapy Product Injures Me?
Whenever a drug recall occurs because of a lack of sterility assurance, it should raise alarms. Improperly sterilized drugs have sickened and even killed people, such as in the New England Compounding Center (NECC) fungal meningitis outbreak that injured more than 700 people and was linked to 64 deaths.
Unsanitary conditions in the manufacturing process can lead to purity problems or defective drugs, which can pose a serious health threat to the public.
Our defective drug attorneys at the law firm of Zoll & Kranz, LLC represent victims and families of victims injured or killed because of recalled drugs.
Zoll & Kranz, LLC – Defective Medical Drug and Device Lawyers