The Greek National Drugs Organization (EOF) has decided the recall of popular stomach and heartburn drug ZANTAC and its generic drug RANITIDINE by MYLAN on September 25, 2019.
EOF’s recall follows the recall of these two products from the US market, as US health officials found that they contain traces of a potential carcinogen NDMA.
According to EOF decision, to recall are:
- ZANTAC EF.TAB 150MG/TAB
- ZANTAC F.C.TAB 150MG/TAB
- ZANTAC INJ.SOL 50MG/2ML AMP
and
- RANTIDINE/MYLAN 150MG F.C. TAB K110115A 9/2019
- RANTIDINE/MYLAN 150MG F.C. TAB K110116A 3/2019
- RANTIDINE/MYLAN 150MG F.C. TAB K110216A 5/2019
According to EOF statement, the decision is “a preventive measure to protect Public Health with a view to reinforcing the company ‘s voluntary recall of the products, following the suspension of the Certificate of Appropriateness by the Saraca Laboratories Limited’ s for the active substance ranitidine.”
The local product “representative must implement the recall within a reasonable time. Records of recall must be kept for at least five (5) years and be available to EOF upon request,” the statement said.
On Thursday, EOF extended the list to
- LUMAREN FC TAB 150 MG
- LUMAREN INJ 50MG/2ML.
On Friday, EOF added one more product on its recall list: PTINOLIN.
The recall by Greek National Drugs Organization follows recall of these two products in the US drugs market. Sandoz said in a statement ” because of confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the FDA.”
N-nitrosodimethylamine (NDMA) is considered as probable carcinogen.
“The NDMA was formerly used in making rocket fuel,” wrote lifescience on Sept 13, 2019, when US health officials found low levels of a potentially cancer-causing chemical in the popular heartburn drug.
“On Friday (Sept. 13), the U.S. Food and Drug Administration (FDA) announced that samples of ranitidine — known by the brand name Zantac — were found to contain a contaminant called N-nitrosodimethylamine (NDMA). That’s the same chemical that was found in heart and blood pressure medications last year, sparking numerous recalls of those affected drugs.
NDMA is classified as a “probable human carcinogen” because it has been found to cause cancer in animal studies, lifescience wrote.
Ranitidine is prescribed for the treatment of active duodenal or benign gastric ulcer; maintenance of healing of duodenal or gastric ulcer; pathological hypersecretory conditions (eg, Zollinger-Ellison syndrome and systemic mastocytosis); GERD; erosive esophagitis; and for maintenance of healing of erosive esophagitis.
 has decided the recall of popular stomach and heartburn drug ZANTAC and its generic drug RANITIDINE by MYLAN){kind=link}