MHRA company-led drug alert – Unlicensed Medicine Phenytoin 90mg/5ml Oral Suspension (Rosemont Pharmaceuticals Ltd)

MHRA company-led drug alert – Unlicensed Medicine Phenytoin 90mg/5ml Oral Suspension (Rosemont Pharmaceuticals Ltd)

May 16, 2018

CLDA number: CLDA (18)A/02

Date issued: 16th May 2018

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a company-led drug recall for certain batches of:

Unlicensed Medicine Phenytoin 90mg/5ml Oral Suspension (Rosemont Pharmaceuticals Ltd)

Batch numbers:

  • 6KL0035 (expires October 2018);
  • 7CL0043 (expires April 2019);
  • 7KL0045 (expires October 2019); and
  • 8BL0033 (expires January 2020).

This product is being recalled 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.

If affected products are found in stock, please refer to the form and instructions provided to you by DRUGSRUS directly.

To view the alert, please visit the GOV.uk website.

 



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