Biogaran laboratory in collaboration with ANSM informs consumers that RANITIDINE BIOGARAN 150 mg film-coated tablet, CIP 34009 349 699 3 5 and RANITIDINE BIOGARAN 300 mg film-coated tablet, CIP 34009 349 858 4 3 are recalled from being marketed.

According to the study, results were not related to the specification of the stability and by the respect of regulation agency of EMA finally the laboratory decided to recall their products for safety to human being.

Indication of Rantidine:

1. Adults

In combination with antibiotic dual therapy, eradication of Helicobacter pylori in cases of gastroduodenal ulcer disease (after endoscopic evidence of lesion and infection).

Evolutionary gastric or duodenal ulcer;

Esophagitis by gastroesophageal reflux;

Zollinger-Ellison syndrome.

2. Children (3 to 18 years)

Short-term treatment of gastric or duodenal ulcers,

Treatment of gastroesophageal reflux, including reflux esophagitis and relief of symptoms related to gastroesophageal reflux.

RANITIDINE BIOGARAN 150 mg film-coated tablet, CIP 34009 349 699 3 5

Lot 1411003 expiry date 11/2017
Lot 1502004 expiry date 02/2018
Lot 1502005 expiry date 02/2018
Lot 1507006 expiry date 07/2018
Lot 1507007 expiry date 07/2018
Lot 1606008 expiry date 06/2019
Lot 1608009 expiry date 08/2019
Lot 1702010 expiry date 02/2020
Lot 1703011 expiry date 03/2020

RANITIDINE BIOGARAN 300 mg film-coated tablet, CIP 34009 349 858 4 3

Lot 1502004 expiry date  02/2018
Lot 1502005 expiry date  02/2018
Lot 1507006 expiry date  07/2018
Lot 1507007 expiry date 07/2018
Lot 1702008 expiry 02/2020
Lot 1702009 expiry date 02/2020
Lot 1411003 expiry date 11/2017
http://ansm.fr