Withdrawn drug: The Chief Pharmaceutical Inspector (GIF) informed about withdrawal from the market throughout Poland a medicinal product Bupivacaine and epinphrine, bupivacaine-epininhrine 0.5 percent(5 mg + 5 mcg)/ml. It is a solution for injection, a 20 ml vial. The product number series is 124076, the expiration date is September 2026. The responsible entity is GeneTetek lifesciences pvt. Ltdand the allowance permit number is DOP/01058/24.
What is the reason for the decision: The Voivodship Pharmaceutical Inspector in Olsztyn received a report to GIF about the speech in the drug qualitative defects. This was also signaled by three hospital units. The drugs were observed change of coloring solution from transparent to iridescent or brown. In the course of the case, no irregularities in pharmacies were found. “According to the statement of the responsible entity: a product with a changed color Do not use” – said GIF. The indicated series is also prohibited product. GIF gives the decision “immediate enforceability”.
Syrup was withdrawn: As we wrote earlier, recently GIF withdrew a series of syrup for Dexapini cough. The reason was crystalline sediment at the bottom of the bottle, and exactly sucrose. Crystallization of sugar reduces its concentration in the remaining liquid, which can theoretically lead to microbiological pollution.
More You can read about this in the text: “An urgent message on a series of syrup for coughing. 'Immediate enforceability'“.
Sources: Register of the decision of the Chief Pharmaceutical Inspector, Gazeta.pl