Medicine recall 16 May 2018

Unlicensed Medicine Phenytoin 90mg/5ml Oral Suspension – company led recall

Yes – this has been recalled

The problem: Rosemont Pharmaceuticals Limited, MS 427 is issuing a company-led drug alert for an unlicensed medicine Phenytoin 90mg/5ml Oral Suspension (CLDA (18)A/02).
What to do: Check the batch number on your pack against the list below. Do not stop taking a prescribed medicine without talking to your pharmacist, GP or prescriber first – they can check your supply and swap it if needed.

Source: Medicines and Healthcare products Regulatory Agency (MHRA) Official notice ↗

Product information

CLDA number

CLDA (18)A/02

MDR number

116-04/18

Company name

Rosemont Pharmaceuticals Limited, MS 427

Product description

Unlicensed Medicine

Phenytoin 90mg/5ml Oral Suspension

Batch number/expiry

Batch No.	Expiry date
6KL0035	Oct 2018
7CL0043	Apr 2019
7KL0045	Oct 2019
8BL0033	Jan 2020

Brief description of the problem

The above batches are being recalled to Pharmacy Level as a precaution due to the generation of data which indicates that the product becomes difficult to resuspend over shelf life. The product is also being discontinued with immediate effect.

Advice for Healthcare Professionals and patients

The recall is to pharmacy level so there is no requirement to recall stock from patients. Healthcare Professionals should, however, contact affected patients to make them aware of the discontinuation of the product and to advise them to contact their doctor as soon as possible to seek alternative medication.

Patients should not stop taking their medicine and should contact their doctor as soon as possible to discuss alternative medication.

Updated 16 May 2018. This page summarises an official notice. Details can change – always follow the official notice.