Dr Reddy's Labs recalls 4320 bottles of Tacrolimus Capsules in US over packaging error
Dr Reddy's initiated the Class II nationwide recall on February 8 this year.
New Delhi: Dr Reddy's Laboratories is recalling over 4,000 bottles of a generic drug in the US due to a packaging error. The Hyderabad-based drug major is recalling 4,320 bottles of Tacrolimus Capsules which are used to prevent the body from rejecting a transplanted organ.
New Jersey-based Dr Reddy's Laboratories Inc, a unit of the company, is recalling the affected lot due to "Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules," USFDA said in its latest Enforcement Report.
The affected lot was produced at the company's Bachupally-based manufacturing plant and marketed in the US by its American arm.
Dr Reddy's initiated the Class II nationwide recall on February 8 this year.
As per USFDA, a Class II recall is initiated in a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Established in 1984, Dr. Reddy’s Laboratories Ltd. is a global pharmaceutical company headquartered in Hyderabad, India. The company offers a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Its major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management, and dermatology. Dr Reddy's major markets include – USA, India, Russia & CIS countries, China, Brazil, and Europe.