Amarox Limited has issued a recall for one batch of Sertraline 100mg film-coated tablets. This decision was made as a precaution following a manufacturing error that resulted in an incorrect packaging incident. Specifically, a sealed carton of Sertraline 100mg contained a blister strip of Citalopram 40mg tablets, which is another antidepressant medication.
Details of the Recall
The recall was prompted by a patient complaint that led to the discovery of this mix-up. Both Sertraline and Citalopram are selective serotonin reuptake inhibitors (SSRIs) used to treat various mental health conditions, including depression and anxiety disorders. The error occurred during the secondary packaging process at the manufacturing site.
Advice for Patients
Patients who have received the affected batch, identified by batch number V2500425, are urged to check their medication. If the blister strips inside the carton are labeled Citalopram 40mg, it is important to contact the pharmacy immediately. In contrast, if they contain Sertraline 100mg, no further action is required.
In case of accidental consumption of Citalopram tablets, patients may experience heightened serotonergic effects. These can include:
- Nausea
- Headache
- Changes in sleep patterns
- Mild anxiety
Guidance for Healthcare Professionals
Pharmacists and healthcare professionals should proactively identify and contact patients who may have received the affected product. They should request the return of any remaining stock. Additionally, it is advisable to discuss treatment options with the patients’ general practitioners, especially for vulnerable individuals such as those over 65, under 18, or with existing medical conditions.
Regulatory Actions
The Medicines and Healthcare products Regulatory Agency (MHRA) has instructed healthcare professionals to cease the supply of the affected batch and return all remaining stock to suppliers. Furthermore, any suspected adverse reactions should be reported through the MHRA Yellow Card scheme.
For further clarification, the MHRA’s Class 2 recall notice contains additional information and images of the affected product. The agency ensures that all medicines and medical devices in the UK are safe and effective, with oversight from the Department of Health and Social Care.
