Due to a packaging error, Dr Reddy’s Laboratories is recalling over 4,000 bottles of a generic drug in the US. 4,320 bottles of Tacrolimus Capsules, which are aimed at preventing the body from rejecting a transplanted organ, are being recalled by the Hyderabad-based pharmaceutical company.
A unit of the company, Dr Reddy’s Laboratories Inc., based in New Jersey, is recalling the affected lot as a result of “the presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labelled as Tacrolimus 0.5 mg capsules,” according to the USFDA’s latest Enforcement Report.
The company’s production facility in Bachupally, India, produced the impacted lot, which its American division then marketed in the United States. On February 8 of this year, Dr. Reddy’s started the Class II nationwide recall.
According to the USFDA, a Class II recall is started when using or being exposed to a product that is in violation may result in short-term or medically treatable adverse health effects or when the likelihood of substantial adverse health effects is remote.