Class 4 Medicines Defect Notification: Blumont Pharma Limited, Ocumont Eye Ointment 1% w/w, EL(26)A/03

Blumont Pharma Limited is reporting to the MHRA regarding the absence of Braille on the outer carton of one batch of Ocumont Eye Ointment 1% w/w (POM). It was identified that the Braille information was inadvertently omitted during the approval and release process.

DMRC Number: DMRC-38025137

Company name:Blumont Pharma Limited

Product description: Ocumont Eye Ointment 1% w/w - PL: 31103/0018, SNOMED code: 42186711000001106, GTIN: 5060148680286

Details of the affected batch:

Background information: 

Blumont Pharma Limited is reporting to the MHRA regarding the absence of Braille on the outer carton of the above-mentioned batch of OCUMONT Eye Ointment 1% w/w (POM). It was identified that the Braille information was inadvertently omitted during the approval and release process.

This issue is limited to a single batch (Lot B0866) that has been distributed. The quality of the ointment is not affected by this defect. All other batches distributed contain the Braille information on the outer carton.

Advice to Healthcare Professionals: 

Healthcare professionals are advised to be aware that the outer carton of the affected batch does not contain Braille. Appropriate support should be provided to patients with visual impairment when dispensing this product, in line with local procedures.

The quality of the ointment is not impacted by this defect, therefore, the affected batch is not being recalled. All other batches of the product contain Braille on the outer carton.

Advice to Patients: 

No action is required from patients. This issue relates to the absence of Braille on the outer carton of a single batch of Ocumont Eye Ointment 1% w/w. The quality of the ointment is not impacted by this defect, therefore, the affected batch is not being recalled. Healthcare professionals will provide appropriate support at the time of dispensing, where required.

Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Company contacts for further information: 

For all medical information enquiries and information on this product, please email info@blumontpharma.com, or telephone + 44 (0)1476 978 568.

For stock control enquiries please email info@blumontpharma.com, or telephone + 44 (0)1476 978 568.

To access the full recall/alert: Class 4 Medicines Defect Notification: Blumont Pharma Limited, Ocumont Eye Ointment 1% w/w, EL(26)A/03