| Reason for the Action |
The contract manufacturer has advised that two Bio Concepts Listed Medicine formulations may have a non-uniform distribution of potassium iodide.
The Risk Assessment completed by the Contract Manufacturer has identified a particle size problem with potassium iodide which might cause nonhomogeneous blend in the powder. Calculations show the potential iodine in these products may be well in excess of the safety limits for iodine or lack amount of iodine.
In mild cases, excess iodine consumption can cause diarrhoea, burning sensation in the mouth, nausea and vomiting. In severe cases, iodine poisoning may involve swelling of airways, cyanosis, weak pulse or coma.
There is also the potential for iodine deficiency if the product is lacking the active ingredient.
The affected products have been distributed since February 2025. No adverse events have been reported to date.
This product recall does not affect any other batches, expiry dates or pack sizes of Orthoplex Pure Children’s Essentials or Orthoplex MagGI Restore, or any other Bio Concepts Orthoplex products.
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