Public Alert No: 0017/2019 – Alert on Genotoxic Impurity, N-Nitrosodimethylamine (N-NDMA) in Zantac and Other Ranitidine Containing Products
October 5, 2019,
The National Agency for Food and Drug Administration and Control (NAFDAC) has been informed that Swissmedic, the National Medicines Regulatory Authority of Switzerland has detected low levels of N-Nitrosodimethylamine (N-NDMA), a genotoxic impurity in Zantac injection 50mg/5ml batch number 669. Genotoxic substances such as N-NDMA are known to be potentially carcinogenic when ingested, inhaled or penetrate the skin.
The impurity was detected by Medicines Control Laboratory of Swissmedic. The value of N-NDMA found was 0.3ppm relative to the active substance. The currently agreed threshold in Europe for NDMA in Ranitidine Hydrochloride is 0.16ppm.
Ranitidine is a medicine used to treat and prevent ulcers of the stomach and intestine. It belongs to a group of medicines known as H2-Blocker. It works by reducing the amount of acid that the stomach produces.
N-NDMA has been classified by International Agency for Research on Cancer (IARC) as probably carcinogenic to humans. It was reported that the impurity was also detected in the active `pharmaceutical ingredient (API) manufactured by Saraca Laboratory.
Following the detection of the impurity, some countries and their National Medicines Regulatory Authorities have taken various actions:
|Switzerland||Swissmedic||Glaxo SmithKline (GSK) instructed to carry out pharmacy/retail level recall of all Zantac batches
in Swiss market.
Swissmedic asked for recall of all ranitidine containing
products from Swiss market.
| HSA tested all locally available ranitidine products for
the presence of nitrosamine compounds and found
that the products contained NDMA. The APIs was
supplied by Dr. Reddy’s Laboratory India and
GSK was instructed to suspend the wholesale supply
and conduct class 2 (retail level) recall of Zantac.
|3||USA||USFDA|| Issued a statement alerting patients and health
care professionals on NDMA found in samples of
|4||Finland||FIMEA|| GSK instructed to implement Pharmacy/retail level recall
of all Zantac products (Tablets, effervescent tablets
and syrups) from the Finish market.
|5||Ireland||HPRA|| Prepare to recall Zantac products manufactured using
API from Saraca Laboratory from Pharmacies and
retail levels in Irish market.
|6||Denmark||DMA|| GSK requested to implement a pharmacy/retail level
recall of all Zantac products (Syrups and injections)
from Danish market.
|7||Saudi Arabia||SFDA|| GSK instructed to carry out a pharmacy/retail level recall
of all Zantac products (Tablets, effervescent tablets,
injections and syrups) from the Saudi market.
|8||Kenya||PBB|| PBB decided that all ranitidine containing products
shall be recalled up to retail pharmacy level by
their respective Marketing Authorization Holders
(MAHs) until proved to be safe.
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 till further notice.
NAFDAC has strengthened surveillance at ports of entry to prevent importation of ranitidine containing products till further notice.
Distributors, wholesalers and retail pharmacies in possession of stock of ranitidine containing products should immediately stop distribution and sale of the products.
Patients on ranitidine containing products are to contact their Healthcare Provider to advise them on alternative treatment.
The members of the public especially Healthcare Providers are advised to be vigilant and contact the nearest NAFDAC office with any information on importation and distribution of ranitidine containing products.
Healthcare Providers and Patients are encouraged to report adverse events or side effects related to the use of medicines to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks) or via firstname.lastname@example.org
NAFDAC……………Safeguarding the health of the Nation!!!