There has been an immediate discontinuation of unlicensed medicine Phenytoin 90mg/5ml Oral Suspension and a recall of the product.
The medication, manufactured by Rosemont Pharmaceuticals Limited, is now no longer on the shelves having been recalled and discontinued with immediate affect as a result of worrying data that suggested that the medication becomes difficult to resuspend over shelf-life.
Patients who use the Phenytoin 90mg/5ml Oral Suspension are being told to contact their doctors for more information and advice about the issues that have been identified.
Batches of Phenytoin 90mg/5ml Oral Suspension affected
The batches of Phenytoin affected by the immediate discontinuation and recall of the medication are as follows
- 6KL0035 (expires October 2018);
- 7CL0043 (expires Aril 2019);
- 7KL0045 (expires October 2019);
- 8BL0033 (expires June 2020).
Stock of the medication is being recalled at pharmacy-level as opposed to patient-level, meaning that patients can continue to use the medication, although healthcare professionals are being advised that contacting patients as a precaution is good practice to allow patients to touch base with their doctors for an alternative medication to be sought.
Patients are also being advised to not stop taking the Phenytoin but should contact their doctor for help and advice.
More information about the recall can be found here.
Medication recalls are common
Medication recalls like the Phenytoin recall are common. It’s normally a requirement for pharmaceutical companies to continually observe and monitor products they put out in to the market to ensure there’s nothing missed.
Where a problem is identified, a recall can be initiated. If it’s serious, discontinuation may occur as we have seen here in the Phenytoin case.