ERIS suspends sale and orders withdrawal of Loratadina MG batch after crystal detection

Praia City, Feb 03 (Inforpress) – The Independent Health Regulatory Authority (ERIS) has ordered the immediate suspension of the sale and withdrawal from the market of batch SN4386 of Loratadina MG® syrup, due to quality issues.

According to a notice published on the regulator’s official website, the measure specifically affects batch SN4386, with an expiry date of 09/2027, of Loratadina MG® 1 mg/mL (syrup), manufactured by Sangeeta Pharma Laboratories.

ERIS explains that the decision was taken following the detection of “insoluble translucent crystals” in some bottles of the medicine. This anomaly indicates a change in the physical properties of the syrup, which may compromise the quality and safety of the final product.

In this context, the regulatory authority urges pharmacies and other sector entities not to sell, dispense or administer units from the affected batch and to proceed with their immediate return.

ET/CP

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