Zydus Lifesciences’ New Jersey-based subsidiary -- Zydus Pharmaceuticals (USA) is recalling over 1,500 boxes of an antiviral medication used primarily to treat chronic hepatitis B virus. Pennington, New Jersey-based Zydus Pharmaceuticals (USA) is recalling 912 and 600 bottles of Entecavir tablets in strengths of 0.5 mg and 1 mg, respectively due to failed impurity/degradation specifications.
The company has initiated the Class II nationwide recall on September 24. As per the US Food and Drug Administration (USFDA), a Class-II recall is initiated when the use of, or exposure to, a violative product may lead to temporary or medically reversible health consequences, or when the likelihood of serious adverse health outcomes is minimal.
Zydus Lifesciences (formerly known as Cadila Healthcare), a company limited by shares, incorporated and domiciled in India, operates as an integrated pharmaceutical company with business encompassing the entire value chain in the research, development, production, marketing and distribution of pharmaceutical products.
