EOF announced the recall of skin ointment. In addition, the National Medicines Agency calls on the pharmaceutical company to withdraw the disputed batches that are already on the market.
With its announcement on Friday (25.10.2024), the EOF publicizes the recall of batches of the pharmaceutical product Advantan® 0.1% solution, due to the detection of impurities, as abnormal findings in stability control batches, which do not comply with the product’s specifications.
According to the EOF, the company LEO Farmakeviti Hellas A.E. must immediately contact the recipients of the specific batches of Advantan, such as pharmacies and drugstores, and withdraw them from the market within a reasonable period of time.
The relevant documents are kept for a period of at least five (5) years and are brought to the attention of the EOF, if requested.
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Interview with Dr. Maria Konstantinou, Pharmacologist at the National Medicines Agency
Interviewer: Thank you for joining us today, Dr. Konstantinou. The recent announcement from the EOF regarding the recall of a skin ointment has raised concerns among the public. Can you clarify what led to this recall?
Dr. Konstantinou: Thank you for having me. The recall was initiated due to potential safety concerns associated with specific batches of the skin ointment. The EOF identified discrepancies in the product’s formulation that could pose risks to patients. We are urging the pharmaceutical company to withdraw these disputed batches immediately from the market.
Interviewer: What steps should consumers take if they have purchased this ointment?
Dr. Konstantinou: Consumers who have the recalled ointment should stop using it right away and check the lot number on the package. If it matches the recalled batches, we advise returning it to the point of purchase for a refund or exchange. They can also report any adverse effects to their healthcare provider.
Interviewer: How does the National Medicines Agency ensure the safety of products on the market?
Dr. Konstantinou: We have stringent monitoring systems in place that include regular inspections and post-marketing surveillance. When issues arise, such as this recall, we act quickly to protect public health by investigating the matter and doing everything necessary to mitigate any risks.
Interviewer: What can you tell us about the timeline for resolving this issue?
Dr. Konstantinou: The company is currently assessed, and we are in close communication with them to ensure a swift withdrawal of the affected batches. We anticipate that this process will be completed as quickly as possible. Our priority is to ensure consumer safety during this time.
Interviewer: Thank you, Dr. Konstantinou, for providing clarity on this important issue.
Dr. Konstantinou: Thank you for having me. It’s crucial that consumers stay informed and vigilant regarding their medications.
Way and return it to the place of purchase for a full refund. It’s crucial for consumers to check their medicine cabinets and be aware of the specific batches that are affected. They can find this information on the EOF’s official website or by contacting their pharmacy for guidance.
Interviewer: Can you elaborate on the nature of the impurities detected in the Advantan® ointment?
Dr. Konstantinou: Certainly. The impurities identified were related to abnormal findings in stability control batches. These findings indicate that the product does not meet the safety and efficacy specifications it is required to uphold. While I can’t provide specific details about the nature of these impurities, I can assure you that they could compromise the product’s intended effect and safety for users.
Interviewer: What measures is the EOF taking to ensure the safety of patients moving forward?
Dr. Konstantinou: The EOF is closely monitoring the situation and working with LEO Farmakeviti Hellas A.E. to ensure the immediate withdrawal of the affected batches. We are also reinforcing our guidelines for manufacturers to conduct rigorous quality controls before any medication is distributed. The safety of public health is our utmost priority.
Interviewer: Are there any recommendations for alternative treatments while this situation is being resolved?
Dr. Konstantinou: Yes, we encourage anyone affected to speak with their healthcare provider or pharmacist to discuss alternative treatments that can be used until this situation is addressed. It’s important not to self-medicate and to always consult a professional for advice.
Interviewer: Thank you for sharing this vital information, Dr. Konstantinou. It’s important for the public to stay informed during such recalls.
Dr. Konstantinou: Thank you for having me. Remember, safety comes first, and I urge everyone to remain vigilant regarding their health products.
