Urgent Recall of VISIPAQUE 320 MG/ML Solution Mandated in Morocco Amidst Contamination Concerns
The Moroccan Agency for Medicines and Health Products (ANAM) has initiated an urgent directive for the nationwide recall of a specific batch of the diagnostic contrast agent, VISIPAQUE 320 MG/ML. This action underscores the agency’s unwavering commitment to safeguarding public health and ensuring the integrity of pharmaceutical products available to Moroccan citizens.
The affected product is a 100 ml solution containing the active ingredient Iodixanolum, a crucial component in various advanced medical imaging procedures, including CT scans and MRIs. Its primary function is to enhance the visibility of internal structures, aiding clinicians in accurate diagnosis.
Details of the Recalled Batch:
- Product Name: VISIPAQUE 320 MG/ML
- Volume: 100 ml
- Active Ingredient: Iodixanolum
- Batch Number: 17271300
The recall was prompted by the discovery of a critical non-compliance issue. Investigations revealed contamination within the packaging vials of batch number 17271300. This contamination was identified after the product had already been distributed and reached market channels, necessitating immediate and decisive action to prevent any potential risk to patients.
Mandatory Actions for Healthcare Professionals and Facilities:
The ANAM has issued clear and unequivocal instructions to all relevant stakeholders within the healthcare supply chain. The directive mandates the immediate cessation of dispensing and usage of the identified batch of VISIPAQUE.
- Healthcare Providers: This includes, but is not limited to, hospital pharmacists, retail pharmacists, wholesalers, and all public health facilities.
- Immediate Action Required:
- Cease all dispensing activities involving batch number 17271300.
- Immediately halt the use of this specific batch in any diagnostic procedures.
- Segregate any existing stock of the affected batch to prevent accidental use.
- Await further instructions regarding the return and disposal of the recalled product.
The agency is coordinating closely with the pharmaceutical company CycloPharma, the entity responsible for the product’s distribution in Morocco, to manage the logistical aspects of the recall. This includes facilitating the return of the contaminated stock and ensuring appropriate procedures are followed for its retrieval and potential disposal.
The ANAM stressed that this proactive measure is a core component of its regulatory mandate. The agency is dedicated to upholding the highest standards of safety, efficacy, and quality for all medicines and health products circulating within the Kingdom. This recall serves as a testament to their vigilance and responsiveness in addressing potential threats to public health. Patients who may have received or are scheduled to receive imaging procedures utilizing VISIPAQUE are advised to consult with their healthcare providers if they have any concerns. Healthcare professionals are urged to remain vigilant and to report any further issues or observations related to pharmaceutical products.
