The Chief Pharmaceutical Inspector announced the suspension of trade in a medicinal product called: Pulmopect (Levodropropizinum); 30mg/5ml; syrup; 1 bottle 200 mlGTIN 05900411007597, for the following series: 24371007A, expiration date: 01/2026, 23371022C, expiration date: 11/2025, 23371024A, expiration date: 11/2025.
Pulmopect is a cough medicine in the form of raspberry-flavored syrup. It is intended for the symptomatic treatment of dry, non-productive cough kids over two years of age and adults. The active substance of the drug is Levodropropizinum.
GIF withdraws popular syrup from pharmacies. We know the reason
As GIF explains, the reason for the decision are reports suspicion of a quality defect. Some of the packaging from the above-mentioned series contained a changed appearance of the drug, which was determined by the applicants, among others:incl. as: “a gelatinous substance floating in syrup, not dissolving when shaken”
As explained by GIF, the grounds for suspending trading in the above-mentioned batches of the medicinal product, there is therefore a justified suspicion that they do not meet the established quality requirements due to the changed appearance of the product, which is inconsistent with the description contained in the Summary of Product Characteristics and the patient leaflet.
In the case in question, the existence of a real risk to health is obvious in the opinion of the authority. A discrepancy in the appearance of a product, without a confirmed cause and determination of the nature of this discrepancy, is a situation that may cause direct negative health consequences for patients.
– we read in the justification of the decision.