MHRA 第4类药品缺陷通报：Blumont Pharma Limited 的 Ocumont Eye Ointment 1% w/w，EL(26)A/03

Contents

1. DMRC reference number
2. Marketing Authorisation Holder
3. Medicine Details
   1. Ocumont Eye Ointment 1% w/w
4. Affected Lot Batch Numbers
5. Background
6. Advice for Healthcare Professionals
7. Advice for Patients
8. Additional information
9. Download document

DMRC reference number

DMRC-38025137

Marketing Authorisation Holder

Blumont Pharma Limited

Medicine Details

Ocumont Eye Ointment 1% w/w

PL: 31103/0018

Active ingredient: chloramphenicol

SNOMED code: 42186711000001106

GTIN: 5060148680286

Affected Lot Batch Numbers

Background

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 for 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 for 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.

Additional information:

For all medical information enquiries and information on this product, please email [email protected], or telephone + 44 (0)1476 978 568.

For stock control enquiries please email [email protected], or telephone + 44 (0)1476 978 568.

Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

Yours faithfully

Defective Medicines Report Centre

10 South Colonnade

Canary Wharf

London

E14 4PU

Telephone +44 (0)20 3080 6574

[email protected]

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