DRAP orders recall of drugs containing Ranitidine

Islamabad: The Drug Regulatory Authority of Pakistan has ordered immediate suspension of production, recall, and stoppage of distribution, sale, supply, and utilization of all dosage forms of Ranitidine-containing drugs.

A medical product alert issued on Thursday states that the regulatory action has been taken in response to a statement of the US FDA and EMA regarding detection of a probable carcinogenic impurity in some products containing Ranitidine.

The FDA and EMA is evaluating the risks associated with low levels of N-nitrosoDimethyline, a carcinogenic impurity and a known environmental contaminant found in water and foods including meats.

“It is requested to initiative recall of Ranitidine-containing drugs available in sale outlets, or with distributors, hospitals, and healthcare facilities under intimation to respective DRAP field offices along with the manufacturing, distribution, and sale records of subject drugs available therewith in comparison of recalled inventory within three days,” the alert states.