Class 4 Medicines Defect Information: Manx Healthcare Ltd., Betamethasone Valerate 0.1% Ointment, EL(24)A/18

Manx Healthcare Ltd. has informed MHRA that they have identified a problem with the product packaging of the batch indicated in the table.

MDR Number: MDR 142-05/24

Company name: Manx Healthcare Ltd.

Product description: Betamethasone Valerate 0.1% Ointment, PL 14251/0010, SNOMED Code 41207211000001102

Details of the affected batch: 

Brief description of 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 to 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 to 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.

Patients who experience adverse reactions or have any questions about the 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 medical information enquiries please contact medinfo@manxhealthcare.com, or telephone: 01926 482511.

For stock control enquiries please contact customerservice@manxhealthcare.com, or telephone: 01926 482511.

To access the full recall: Class 4 Medicines Defect Information: Manx Healthcare Ltd., Betamethasone Valerate 0.1% Ointment, EL(24)A/18