The Chief Pharmaceutical Inspector (GIF) withdrew two batches of the drug called Sugammadex Reig Jofre from circulation throughout the country. The reason is a quality defect. The GIF made the decision immediately enforceable.
The Chief Pharmaceutical Inspector informed about the withdrawal from the market throughout the country of a medicinal product called:
Sugammadex Reig Jofre (Sugammadexum) 100 mg/mLsolution for injection, 10 vials of 2 mlGTIN: 05909991515294, for two series: 23203Vexpiration date: 30/06/2026 and 24201expiration date: 30/06/2027.
The responsible entity is Reig Jofre based in Warsaw.
GIF banned the marketing of the above-mentioned batches of the medicinal product throughout the country.
The GIF made the decision immediately enforceable.
Justification of the decision
“The Chief Pharmaceutical Inspectorate received a notification from the responsible entity – Reig Jofre sp. z o. o. based in Warsaw, regarding a quality defect of the medicinal product Sugammadex Reig Jofre, 100 mg/mL, solution for injection, in the scope of batch number 23203V with the expiry date: 30/06. 2026 and batch number 24201 with an expiration date: June 30, 2027. The reported defect consists in the appearance of visible silicone particles in the solution of the above-mentioned product batch,” we read in the justification of the decision.
It was added that based on the results obtained, the MAH recommended withdrawing the above-mentioned product from the market. series of the medicinal product.
GIF reported that a potential risk to patients from the injection of visible silicone particles could not be ruled out. “Therefore, the risk to human health resulting from leaving the batches of the medicinal product in question on the market is real and probable,” it was emphasized.
What kind of medicine is this?
Sugammadex Reig Jofre is considered a selective muscle relaxant binder because it only works with specific muscle relaxants – rocuronium bromide or vecuronium bromide.
As we read in the leaflet, it is used when certain types of surgery are necessary, during which the patient's muscles must be completely relaxed.
“For this purpose, muscle-relaxing drugs are administered during general anesthesia. These are called muscle relaxants and include rocuronium bromide and vecuronium bromide. Since these drugs also cause relaxation of the respiratory muscles, assisted breathing (artificial ventilation) is necessary during surgery and after surgery until the patient's own breathing returns. Sugammadex Reig Jofre is used to accelerate the return of muscles to their normal condition after surgery, to restore the patient's ability to breathe on his own earlier,” it explained.
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