BackDr.Reddys halts worldwide supply of Ranitidine until FDA probe over
Ranitidine is an over-the-counter and prescription drug which decreases the amount of acid created by the stomachThe FDA in a statement on 13 September had said it is working with international regulators and industry partners to determine the source of N-nitrosodimethylamine impurity in Ranitidine
PremiumHyderabad: Dr. Reddy’s Laboratories Ltd on Sunday said that it is suspending supply of its drug Ranitidine worldwide as a precautionary measure, following the ongoing probe by the US Food and Drug Administration (FDA) into the reported impurity N-nitrosodimethylamine in it at low levels.
Ranitidine is an over-the-counter and prescription drug which decreases the amount of acid created by the stomach.
“Dr. Reddys is still evaluating potential impact of the issue. As a precautionary measure, Dr. Reddys is suspending all shipments worldwide of Ranitidine products until the investigation (by the FDA) outcome is available.
We have both a prescription and an over-the-counter portfolio of the product," Dr. Reddys spokesperson told PTI in an email reply.
The FDA in a statement on 13 September had said it is working with international regulators and industry partners to determine the source of this impurity in Ranitidine being manufactured by several companies RPT being manufactured by several companies and examining levels of NDMA in Ranitidine and evaluating any possible risk to patients.
Though the FDA is not calling for individuals to stop taking Ranitidine at this time, however, patients taking the prescription and wishing to discontinue its use should talk to their health care professionals about other treatment options, the US drug regulator said.
Unlock a world of Benefits! From insightful newsletters to real-time stock tracking, breaking news and a personalized newsfeed – it's all here, just a click away! Login Now!
