The Saudi Food and Drug Authority has withdrawn all formulations of the GLUCARE XR tablets, for exceeding the acceptable daily intake of impurities called “Nitrosamines”.

The Saudi FDA has been investigating the presence of impurities in some types of medications.

Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines.

US FDA, in collaboration with regulatory counterparts around the world, has set internationally-recognised acceptable daily intake limits for nitrosamines. If drugs contain levels of nitrosamines above the acceptable daily intake limits, FDA recommends these drugs be recalled by the manufacturer as appropriate.

Nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time, but a person taking a drug that contains nitrosamines at-or-below the acceptable daily intake limits every day for 70 years is not expected to have an increased risk of cancer.

The Saudi FDA obligated the drug manufacturer, which is used as a medicine for diabetics, to recall its products from the market, and advised drug users to consult the physician to determine a suitable alternative before stopping it completely, so as not to lead to uncontrolled sugar levels.

The Saudi FDA obligated the drug manufacturer, which is used as a medicine for diabetics, to recall its products from the market, and advised drug users to consult the physician to determine a suitable alternative before stopping it completely, so as not to lead to uncontrolled sugar levels.

SOURCE : GULF NEWS