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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:

S/N Country Regulator Action Taken
    1.

 

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.

2. Singapore HSA

 

 

 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

Saraca Laboratory.

 

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

ranitidine.

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 pharmacovigilance@nafdac.gov.ng

NAFDAC……………Safeguarding the health of the Nation!!!

Signed Management