Precautionary recall has been issued over topical medicine, Diltiazem HCl 2% Cream

Quantum Pharmaceutical has issued a medicinal recall for three batches of Diltiazem HCl 2% Cream, an unlicensed medicine.

What is Diltiazem HCl 2% Cream?

Diltiazem HCl 2% Cream is a topical cream used to heal small cuts and tears on the skin inside your anus. According to NHS, it also helps reduce the pain of the cut and works by:

relaxing the muscle (sphincter) in the back passage (anus), reduces pressure and increases blood flow to the area to allow healing to occur.

It is an unlicensed medicine which means that it is not 'officially approved' for your condition but will be prescribed to you if your doctor thinks it is safe and effective.

The Defective Medicines Report Centre issued a precautionary recall over the cream due to a change in the product's consistency, which now resembles a lotion rather than a cream.

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Which products are affected?

The affected product is Diltiazem HCl 2% Cream with the following details:

• Batch number: M1402497 Expiry date: 20 Sep 2023 Pack size: 30g Date first distributed: 22 Jun 2023
• Batch number: M1402574 Expiry date: 21 Sep 2023 Pack size: 30g Date first distributed: 27 Jun 2023
• Batch number: M1402680 Expiry date: 24 Sep 2023 Pack size: 30g Date first distributed: 07 Jul 2023

Are there any health risks?

The change in consistency of the batches is the primary concern, however there have been no reported side effects so far. While patients may experience issues with the application of the cream due to its altered consistency, there is no evidence to suggest a loss of product efficacy or a risk to patient safety.

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What to do if you have the product

If you are a healthcare professional or wholesaler, immediately stop supplying the affected batches of Diltiazem HCl 2% Cream. Isolate the remaining stock and coordinate the return process with Quantum Pharmaceutical.

If you are a patient who has been using Diltiazem HCl 2% Cream, contact your pharmacist or doctor for advice regarding the affected batches. Quantum Pharmaceutical is making arrangements to supply patients with unaffected batches where possible.

And finally, if you suspect any defects in the medicine or experience any side effects associated with its use, please report them via the Yellow Card scheme.

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Sources used:

GOV.UK