Precautionary Recall of Berifen® 75 Mg IM in Ecuador
Recall Reference:
Acino, part of Arcera is voluntarily recalling Berifen® 75 mg IM, with sanitary registration No. 2663-MEE-0417, lot 172380. This recall is initiated as a precautionary measure due to an out-of-specification (OOS) result in the visible particle test identified during the accompanying stability studies of the product.
Following a thorough internal Health Risk Assessment (HHA), it has been decided to withdraw the affected batch from the distributors’ warehouses and partners’ supply chain, to ensure protection of public health and compliance with the regulatory requirements established by ARCSA. This approach is based on the potential health risk associated with the identified problem, considering the probability of occurrence, the potential clinical consequences, the detectability of the defect and the overall impact on patients and consumers.
This recall has been notified to the National Agency for Regulation, Control and Health Surveillance (ARCSA) of Ecuador on October 14, 2026.
The safety of our customers is our priority. We apologize for the inconvenience and we are working to resolve this as quickly as possible.
Below are photos of the affected product:
If you have any questions regarding this retreat, please do not hesitate to contact Jaime Logroño at the 0991387527 phone number.
The company remains available to answer queries through its official contact channels, available on this website. For reporting an adverse event, please contact us through the official pharmacovigilance channel: notifica@punto-seguro.com.
Sincerely,
Richard Bueno,
General Manager
Acino Pharma Ecuador S.A.