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16 May 2018 by Hilary Cunningham

Company led drug recall: Unlicensed Phenytoin 90mg/5ml Oral suspension

  • Wales
  • England
  • Scotland
  • Northern Ireland

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).

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 re-suspend 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.

Company contact for stock enquiries: Email: Rosemont.customerservices@perrigouk.com

Company contact for medical info: Email: RosemontPharmacovigilance@perrigouk.com

Company contact for quality related enquiries: Email: Anne.ogrady@perrigouk.com

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