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MHRA recalls Diltiazem HCl Cream and Sodiofolin Solution batches


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The Medicines & Healthcare products Regulatory Agency has initiated a recall of three batches of Quantum Pharmaceutical’s Diltiazem HCl 2% Cream, which is an unlicensed medicine. MHRA issued a precautionary recall of the cream due to a change in the product’s appearance that affected its thickness.

Pharmacists are instructed to halt supply, quarantine remaining stock, and contact Quantum Pharmaceutical to return affected batches M1402497M1402574, and M1402680.

Patients using this product may encounter application issues with the cream due to its consistency. However, MHRA said that this has not impacted the product’s effectiveness or posed any risk to patient safety.

The MHRA also reported that medac GmbH (t/a medac Pharma LLP) is conducting a recall of two batches of Sodiofolin 50 mg/ml solution for injection/infusion (400mg/8ml vial) with batch numbers G220393B and G220393C. This class 2 medicines recall is a result of particles detected during long-term stability tests.

Specific batches are being recalled due to pink discolouration of the dacarbazine solution immediately after reconstitution (after correct preparation and storage), MHRA said. “Stop supplying the above batches immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.”

The MHRA recently issued a class 2 medicines recall for Sabril 500 mg film-coated tablets and Sabril 500 mg granules for oral solution. Sanofi UK initiated the recall of these batches as a precautionary measure after detecting traces of tiapride in the source material batches from the manufacturer for vigabatrin.


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