Company Led Medicines Recall: Diltiazem HCl 2% Cream [unlicensed medicine] – Quantum Pharmaceutical

CLMR number: CLMR (23)A/05

Date issued: 19 July 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a company-led medicines recall for: Diltiazem HCl 2% Cream [unlicensed medicine] – Quantum Pharmaceutical

MDR Number: MDR 023-07/23

Company name: Quantum Pharmaceutical

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

Lot number/expiry

Product name Batch number Expiry date Pack size Date first distributed
Diltiazem HCl 2% Cream [unlicensed medicine] M1402497 20 Sep 2023 30g 22 Jun 2023
Diltiazem HCl 2% Cream [unlicensed medicine] M1402574 21 Sep 2023 30g 27 Jun 2023
Diltiazem HCl 2% Cream [unlicensed medicine] M1402680 24 Sep 2023 30g 07 Jul 2023

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 for healthcare professionals and wholesalers

  • 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 for 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 contact for medical information enquiries

Company contact for stock enquiries

To view the alert please visit the GOV.UK website.