The National Administration of Drugs, Food and Medical Technology (Anmat) today requested the withdrawal from the market of two drugs, one ophthalmologic and one healingit was officially reported.
The first of these is an ophthalmological medication, known as Dorzolamide T Dorfbecause osmolarity values out of specification were detectedreported from the control entity.
Osmotic concentration, commonly known as osmolarity, is the measurement of solute concentration, defined as the number of osmoles of a solute per liter of solution.
The control entity requested the withdrawal of the drug whose certificate number is 50913, lot 020Z01 and with an expiration date of March 2024.
The second medicine is a healing, antiseptic and anesthetic product local known as Sulfadina, produced by the Biosintex SA laboratory, where the control entity detected a method not authorized by this Administration.
According to Anmat, for the launch of this product it was used, in the quantification of Vitamin A Palmitate, a non-specific method and not authorized by Anmat.
controlling entity requested the withdrawal of the Sulfadina cream in a 400-gram container whose lots are: 57761, expiration: 06/23; 59471, Expiration: 07/23; 64381, Expiration: 08/23; 805Y1, expiration: 11/23; and 96332, expiration: 03/24
In addition, he requested the withdrawal of the 30-gram containers of the aforementioned product with the following batches: 23890, expiration: 09/22; 64381, Expiration: 08/23; 776Y1, expiration: 11/23; 96332, due: 03/24; and 02042, expiration: 04/24.
In both cases, the National Administration is monitoring the withdrawal from the market and recommends that the population refrain from using the detailed lots.