Medicines Healthcare Products Regulatory Agency
CLMR Number
CLMR (23)A/05
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 products 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
enquiries@quantumpharama.co.uk
Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Yours faithfully,
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574