Due to a packaging error with over 4,000 bottles of a generic drug in the United States, Dr Reddy’s Laboratories is recalling them, news agency PTI reports.
As many as 4,320 bottles of Tacrolimus Capsules are being recalled by the Hyderabad-based pharmaceutical company. Tacrolimus, which belongs to a group of drugs known as immunosuppressive agents, is used along with other medicines to prevent the rejection of a transplanted organ, such as a kidney, liver, heart or lung, in the body, according to Mayo Clinic. Tacrolimus could be administered with steroids, azathioprine, mycophenolate mofetil, or basiliximab. Tacrolimus inhibits calcineurin, which activates T cells of the immune system. Therefore, tacrolimus is used as a calcineurin inhibitor to prevent the immune system from rejecting the graft.
The unit which is recalling the bottles is based in New Jersey. According to a PTI report, the United States Food and Drug Administration (USFDA) said in its latest Enforcement Report that the affected lot is being recalled due to the “presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules”.
The affected lot was produced at a manufacturing plant based in Bachupally, Telangana. The bottles were marketed in the United States by Dr Reddy’s Laboratories American arm, according to the PTI report.
On February 8, 2023, Dr Reddy’s Laboratories initiated the Class II nationwide recall.
Class II recall is one which is issued on products that have a lower chance of causing major injuries or death, but where there is still the possibility of adverse events that could be severe enough to result in irreversible consequences, according to the County of Los Angeles Public Health.
According to the FDA, a Class II recall is issued in a situation where the use of or exposure to a product may result in temporary or medically reversible adverse health effects, or where the probability of serious adverse health events is remote.