Health Boards
Class 4 Medicines Defect Information: Manx Healthcare Ltd., Betamethasone Valerate 0.1% Ointment, EL(24)A/18
Quote:
MDR number: 142-05/24
Company name: Manx Healthcare Ltd.
Product name: Betamethasone Valerate 0.1% Ointment, PL 14251/0010
SNOMED Code: 41207211000001102
Batch Number: G0039
Expiry Date: Feb-2027
Pack Size: 30g
First Distributed: April 2024
Active Pharmaceutical Ingredient: Betamethasone valerate
Brief description of the problem
Manx Healthcare Ltd. has informed MHRA that they have identified a problem with the product packaging of the batch indicated in the table. The tamper-evident seal on the outer carton may be missing or deformed on some packs. This is due to an intermittent equipment fault during secondary packaging.
Advice for healthcare professionals
The quality of the ointment is not impacted by the defect. Any packs from this batch of product with missing or deformed seals may be dispensed. Healthcare professionals dispensing this medication may wish to advise patients that the seal on the outer carton may be broken but this will not affect product quality.
Advice for patients
The quality of the ointment is not impacted by the manufacturing issue as it only affects the outer carton. The tube of ointment that the patient receives will be sealed. Patients should continue to take medicines from this batch as prescribed by your healthcare professional.
Source: gov.uk