ERIS Suspends Sales and Orders Recall of a Batch

Africa-Press – Cape verde. The Independent Health Regulatory Entity (ERIS) has ordered the immediate suspension of the sale and the withdrawal from the market of batch SN4386 of the Loratadine MG® syrup due to quality problems, as reported by Inforpress.

According to a statement published on the regulator’s official website, the measure specifically affects batch SN4386, expiring in 09/2027, of the Loratadine MG® 1 mg/mL (syrup) medication, manufactured by Sangeeta Pharma Laboratories.

ERIS explains that the decision was made after the detection of “insoluble translucent crystals” in some bottles of the medication. This anomaly indicates an alteration in the physical properties of the syrup, which is likely to compromise the quality and safety of the final product.

In this regard, the regulatory authority appeals to pharmacies and other entities in the sector not to sell, dispense, or administer units of the batch in question, and to proceed with their immediate return.

To patients currently using medication from this specific batch, ERIS advises not to interrupt treatment, but recommends that they request, as soon as possible, a replacement package from a different batch at pharmacies.

The organization assures that it will continue to monitor the situation and reinforces to healthcare professionals and users the importance of reporting any problems or adverse reactions related to medications.

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