[NAFDAC Public Alert, October 5, 2019] – The National Agency for Food and Drug Administration and Control (NAFDAC) has directed distributors, wholesalers and retail pharmacies in possession of stock of ranitidine containing products to immediately stop distribution and sale of the products. This follows findings of low levels of N-Nitrosodimethylamine (N-NDMA), a genotoxic impurity, in Zantac injection (50 mg/5 mL Batch No. 669) by Swissmedic, the National Medicines Regulatory Authority of Switzerland.
Genotoxic substances such as N-NDMA are known to be potentially carcinogenic when ingested, inhaled or penetrate the skin. The US FDA and other National Medicines Regulatory Authorities have taken similar steps in recalling and suspending further sale and distribution of ranitidine containing products.
The Marketing Authorization Holder (MAH) of Zantac in Nigeria, Glaxo SmithKline (GSK) has confirmed to the Agency that Zantac is no longer imported into Nigeria. The last batch of Zantac that was imported into Nigeria expired in November 2018.
NAFDAC implores all Pharmaceutical importers to stop importation of all ranitidine containing products until further notice.
NAFDAC has strengthened surveillance at ports of entry to prevent importation of ranitidine containing products until further notice.
Patients on ranitidine containing products are to contact their Healthcare Provider to advise them on alternative treatment.
Healthcare professionals and patients are advised to be vigilant and report any information on importation and distribution of ranitidine containing products to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks) or via pharmacovigilance@nafdac.gov.ng