Company led medicines recall: Quantum Pharmaceutical, Diltiazem HCI 2% Cream [unlicensed medicine], CLMR (23)A/05

Company led medicines recall: Quantum Pharmaceutical, Diltiazem HCI 2% Cream [unlicensed medicine], CLMR (23)A/05

The company has informed us that the consistency of the product within the batches has a reduced viscosity and more closely resembles a lotion than a cream.

CLMR Number: CLMR (23)A/05

MDR Number: MDR 023-07/23

Company name: Quantum Pharmaceutical

Product description: Diltiazem HCl 2% Cream [unlicensed medicine]

Details of the affected batches:

Brief description of problem:

Quantum Pharmaceutical has informed the MHRA that the consistency of the product within the batches mentioned in this notification has changed. The product has a reduced viscosity and more closely resembles a lotion than a cream.

These batches are being recalled as a precautionary measure. This recall is being issued as a company-led recall due to the limited number of packs distributed, and Quantum Pharmaceutical has full traceability of the onward distribution by their customers.

Advice to Healthcare Professionals:

• Stop supplying the batches above immediately. Quarantine all remaining stock and liaise with Quantum Pharmaceutical on the return process.
• Quantum Pharmaceuticals has full traceability and will contact pharmacy teams that have been provided the affected products.

Advice to Patients:

• Quantum Pharmaceutical is recalling 3 batches of Diltiazem HCl 2% Cream as a precautionary measure. This is due to the change in product appearance affecting the thickness of the cream (consistency). They have received no reports of any side effects.
• Patients using this product may experience issues with the application of the cream due to its consistency. However, this does not appear to have affected the product’s efficacy or pose a risk to patient safety.
• Patients should contact their pharmacist or doctor for advice regarding the affected batches. Where identified, arrangements are being made by Quantum Pharmaceutical to supply patients with unaffected batches.
• Any suspected defect of the medicine or side effects associated with use should be reported via the Yellow Card scheme.

Company contacts for further information:

Medical Information enquiries medinfo@quantumpharma.co.uk

Stock enquiries enquiries@quantumpharama.co.uk