MHRA Class 4 Medicines Defect Information: Betamethasone Valerate 0.1% Ointment (Manx Healthcare Ltd.)

Class 4 Medicines Defect Information: Betamethasone Valerate 0.1% Ointment (Manx Healthcare Ltd.)

Drug alert number: EL (24)A/18

Date issued: 03 June 2024

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for: Betamethasone Valerate 0.1% Ointment (Manx Healthcare Ltd.)

Company name: Manx Healthcare Ltd.

Product name: Betamethasone Valerate 0.1% Ointment, PL 14251/0010

SNOMED Code: 41207211000001102

Batch Number Expiry date Pack size First distributed
G0039 Feb-2027 30g 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.

View full alert here.

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.

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.

Further Information

For medical information enquiries please contact medinfo@manxhealthcare.com, or telephone: +44 (0)1926 482511.

For stock control enquiries please contact customerservice@manxhealthcare.com, or telephone: +44 (0)1926 482511.

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