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Haiti - FLASH : Recall of drugs containing Ranitidin
17/04/2020 09:36:59

Haiti - FLASH : Recall of drugs containing Ranitidin
The Ministry of Public Health informs distributors of pharmaceutical products, health professionals and the general public that a recall of drugs containing Ranitidine is launched across the country. Recall that ranitidine is used in the treatment and prevention of various conditions such as stomach ulcers and gastroesophageal reflux.

This recall is being carried out in several countries as a precaution following the presence of a nitrosamine impurity called N-nitrosodimethylamine at low concentrations in the active substance used in the composition of batches based on ranitidine.

Current evidence suggests that impurity may be present in ranitidine, regardless of the manufacturer or the commercial formulation. As such, the Ministry of Health advises all importers that no new application for import authorization will be granted for ranitidine-based products and requests holders of the Marketing Authorization to proceed with the immediate recall of these products to the market.

Patients currently taking ranitidine containing medicines should refer to their doctor or pharmacist for other treatment options available.

This measure is provisional and preventive and investigations are underway in collaboration with other international regulatory bodies.

The Ministry of Public Health counts on the collaboration of all for the strict application of this measure which aims to guarantee consumer safety.

HL/ HaitiLibre

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