Class 4 Medicines Defect Notification: Chloramphenicol 1% w/w Eye Ointment, Blumont Pharma Limited, EL(25)A/20
Blumont Pharma Limited has informed the MHRA of an error with the European Article Number (EAN) barcode on the cartons of the batch of Chloramphenicol 1% w/w Eye Ointment (POM version only) in the below table.
DMRC reference number
DMRC-35465724
Marketing Authorisation Holder
Blumont Pharma Limited
Medicine Details
Chloramphenicol 1% w/w Eye Ointment
PL: 31103/0021
Active ingredient: chloramphenicol
SNOMED code: 42186711000001106
GTIN: 5060148680361
Affected Lot Batch Numbers
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| C0233 | 03/2029 | 4g tube | 25.04.2025 |
Background
Blumont Pharma Limited has informed the MHRA of an error with the European Article Number (EAN) barcode on the cartons of the batch of Chloramphenicol 1% w/w Eye Ointment (POM version only) in the above table. The EAN for Chloramphenicol 0.5% eye drops 10ml (POM) has been included in error on the one batch of Chloramphenicol 1% w/w Eye Ointment (POM). The quality of the medicine is not impacted by the labelling defect.
Advice for Healthcare Professionals:
Healthcare professionals and recipients of this notification are advised not to use these batches of medicine in robotic or automated dispensing or stocking systems and to carry out manual dispensing and stocking, as appropriate.
Blumont Pharma Limited have confirmed that the defect is limited to the one batch of product in the above table.
Product quality of the Chloramphenicol 1% w/w Eye Ointment (POM) is not impacted by this issue; the barcode on the defective packs will identify Chloramphenicol 0.5% eye drops 10ml (POM), having the same active ingredient, same indication (Bacterial conjunctivitis) and the same duration of use, therefore the affected batches are not being recalled.
Advice for Patients:
No action is needed from patients, continue to take this medication as prescribed. The issue is related to the wrong barcode on the cartons of the listed batch of Chloramphenicol 1% w/w Eye Ointment (POM) and will be controlled by the healthcare professional’s prescribing/dispensing the medication. The quality of the medication is not affected.
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 medical information enquiries please email info@blumontpharma.com, or telephone 01476978568
For stock control enquiries please email manoj@blumontpharma.com, or telephone 01476978568
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
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