The Spanish Agency for Medicines and Health Products (AEMPS) has had knowledge through the manufacturing company Noventure de la withdrawal of the Aprotecol pediatric oral suspension, 20 ml (reference 1290998) as a result of a case of severe allergic reaction occurred in France to an eight-day-old baby, who had to be assisted in the emergency department.
Baby colic is one of the biggest concerns of recent parents who see their children suffer and cry without knowing how to help them. There are methods to relieve them naturally since medications are not usually indicated, and in case of doing so, it should always be indicated by the pediatrician for the specific problem of each baby.
Aprotecol, distributed in Spain through the company Ferrer Internacional, is a product for the treatment of Aerophagia, meteorism and flatulent colic in infants and children. The solution is administered in drops and in its leaflet it indicates that it contains probiotics and xyloglycan to improve the intestinal flora of the baby, which help treat the gases and colic of the baby and young children.
But does not specify from what age it can be administered, therefore, it has been withdrawn from sale:
AEMPS reports the withdrawal of the Aprotecol pediatric oral suspension from the market, manufactured by Noventure S.L., Spain, because the instructions for use and the minimum age of the patients are not correctly defined, which can cause potential health risks or errors in the administration of the product.
It has proceeded to withdrawal of all distributed lots from the markets to date and will modify the instructions for use to correctly define the minimum age of the patient and how to administer the product.
Lots removed
- Lot G1290 M, Expiration 06/2020
- Lot G1444 M, Expiration 07/2020
- Lot G1444 SM, Expiration 07/2020
- Lot G2754 M, Expiration 12/2020
- Lot G2754 SM, Expiration 12/2020
If you have any of these lots, do not use the product and contact the establishment where you bought it for return. Also, watch your baby and see a doctor if any discomfort appears.
Via | AEMPS
In Babies and more | Infant colic: how to help you stop crying, How to relieve infant colic
