It is a medicine that provides iron to red blood cells, treats states of iron deficiency and cures anemia (decrease in hemoglobin level and the number and dimensions of red blood cells) , because of this lack of iron. Ferplex is especially indicated in states of iron deficiency that occur during pregnancy and lactation. Now Aemps (Spanish Agency for Medicines and Health Products) has warned of its withdrawal from the market due to a “quality defect that does not present a significant risk to the patient.”
Therefore, all the distributed units of the affected batches were removed from the market and returned to the laboratory through the usual channels. How many are affected?
Distributed as FERPLEX 40 mg ORAL SOLUTION, 20 oral vials of 15 ml:
Lot: 23111, expiration date 05/31/2025
Lot: 23123, expiration date 06/30/2025
Lot: 23124, expiration date 06/30/2025
Lot: 23129, expiration date 06/30/2025
Lot: 23132, expiration date 06/30/2025
Lot: 23135, expiration date 07/31/2025
Lot: 23136, expiration date 07/31/2025
Lot: 23141, expiration date 07/31/2025
Lot: 23155, expiration date 07/31/2025
Lot: 23162, expiration date 07/31/2025
Lot: 23164, expiration date 07/31/2025.
This medicine comes in the form of a clear, brown oral solution with a characteristic odor. Each container contains 20 vials and the holder of the marketing authorization and responsible for the manufacture is ITALFARMACO SA
The active ingredient is Iron proteinsuccinylate (containing milk protein). Each 15 ml vial of oral solution contains 800 mg of iron proteinsuccinylate, equivalent to 40 mg of iron. Other ingredients are: sorbitol (E-420), propylene glycol, propyl parahydroxybenzoate sodium salt (E-217), methyl parahydroxybenzoate sodium salt (E-219), sodium saccharin, blackberry aroma, sodium hydroxide and water.
If you take this medicine, contact your doctor or pharmacist to find out what to do.
