Unlicensed Medicine Phenytoin 90mg/5ml Oral Suspension - company led recall
Read the official alert on GOV.UK — MedRegWatch re-presents it; GOV.UK is the authoritative source.
| Type | Medicines recall/notification |
|---|---|
| Issued | 16 May 2018 |
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.
Company contact for stock enquiries
Email: Rosemont.customerservices@perrigouk.com
Company contact for medical information
Email: RosemontPharmacovigilance@perrigouk.com
Company contact for quality related enquiries
Email: Anne.ogrady@perrigouk.com