Group items tagged

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 M1402497, M1402574, 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.

The Medicines and Healthcare products Regulatory Agency (MHRA) has recalled Labetalol 200mg tablets (Tillomed Laboratories Ltd) directed to pharmacies and wholesalers. Manufacturer, Tillomed Laboratories is recalling one batch of Labetalol 200mg tablets due to an error on the foil blister packaging. The incorrect aluminium foil blister packaging states Labetalol 100mg tablets, however it should be labelled as Labetalol 200mg Tablets. This error has occurred at the primary packing operation. Tillomed Laboratories Limited has confirmed the actual tablet contained in the blister is Labetalol 200mg Tablets, which is the strength stated on the outer carton. This error is limited to the packaging of the batch with 100mg aluminium foil blister and does not impact the lot (batch) number or expiry as printed on the outer carton and aluminium foil blister. Healthcare professionals has been advised to stop supplying the batches immediately. Quarantine all remaining stock and return it to supplier using supplier's approved process.

The Royal Pharmaceutical Society (RPS) has confirmed that the recall of blood pressure drugs amlodipine and olmesartan by the Food and Drug Administration is only for the US market and will not have any impact in the UK. MHRA also clarified that the manufacturer of these drugs, Macleod Pharmaceuticals, does not supply amlodipine medicines in the UK. It was published online in both the Daily Record and Daily Express on the morning of Monday, March 21, that the drugs had been recalled in the US by the FDA due to deviations from standard manufacturing protocols by the manufacturer. RPS intervened to ensure the articles were edited to make clear that this is not an issue in the UK after confirmation from the MHRA. Amlodipine tablets from Macleod Pharmaceuticals aren't available for wholesale distribution in the UK.

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 3 medicines recall for Sildenafil 100mg Film-coated Tablets (Strandhaven Limited T/A Somex Pharma). Manufacturer of drug, Strandhaven Limited T/A Somex Pharma has informed the MHRA that the pack size on some cartons of the batch state 8 tablets instead of 4 tablets. This is an error due to cartons being mixed at the printers. All cartons with batch number ET22028 contain one blister strip of 4 tablets regardless of whether it states 8 tablets or 4 tablets on the pack. Only the batch number ET22028 is affected. Due to the low number of complaints received, only the packs labelled as containing 8 tablets are being recalled at this time. The batch is comprised of 60340 packs, to date 195 packs have been found to be mislabelled.

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 2 medicines recall for Sabril 500 mg film-coated tablets & Sabril 500 mg granules for oral solution. Sanofi UK has recalled the batches of Sabril tablets and Sabril granules as a precautionary measure due to the detection of traces of tiapride in the batches of the source material of the manufacturer for vigabatrin. Sabril (vigabatrin) is indicated for adjunctive treatment of focal seizures with or without secondary generalisation not satisfactorily controlled with other antiepileptics (under expert supervision) and monotherapy in the treatment of infantile spasms (West's syndrome). All patients are advised not to discontinue Sabril tablets or Sabril granules without consulting with their prescriber. The risks of suddenly stopping medication for seizures/epilepsy is higher than the potential risk presented by the presence of tiapride. Sanofi UK have confirmed to DHSC that no other batches are impacted, and other stock remains available.

PCCA Limited has issued a recall for its Ketamine 50mg/5ml and 100mg/5ml oral solutions after a small number of bottles have been observed to contain crystalline material. The company said it is recalling impacted batches from patients, pharmacies and hospitals as a precautionary measure. "This recall is being issued as a company-led medicines recall, as this product is only supplied to a small number of customers and the company has traceability of the onward distribution by their customers to patients directly," the MHRA said in an alert. Check the website.

Pfizer has recalled all stocks of Accupro - including 5mg, 10mg, 20mg, 40mg film-coated tablets - as a precautionary measure due to the identification of a nitrosamine above the acceptable limit. "Following testing, N-nitroso-quinapril, has been observed at a level above the acceptable limit. Nitrosamines may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time. The recall is at pharmacy and wholesaler level," the Pharmaceutical Services Negotiating Committees (PSNC) reported. The Department of Health and Social Care (DHSC) said: "All strengths of quinapril (Accupro) tablets have been recalled with a resupply date to be confirmed. Pfizer are the sole supplier of quinapril tablets in the UK. Alternative ACE inhibitors remain available and can support an uplift in demand."

Three batches of Mexiletine hydrochloride 50mg, 100mg and 200 mg hard capsules manufactured by Clinigen Healthcare has been recalled. Pharmacists are urged to quarantine the said batches and return it to the supplier by or before 12 August. Clinigen Healthcare Ltd has initiated a recall of three batches of Mexiletine hydrochloride hard capsules due to a potential risk of under dose or overdose, which could have consequences for the safety of patients. The manufacturer has confirmed that no alternative batches of Mexiletine hydrochloride 50mg, 100mg or 200mg hard capsules will be available until later in the year, therefore the recall of these batches from patients should only be considered where patients have access to appropriate alternative products. See below for more information on resupplying patients with alternative products. "Patients should be advised not to stop any treatments without consulting their relevant healthcare professional. The risks of suddenly stopping medication for ventricular arrhythmias is higher than the potential risk presented by too much or too little of the active ingredient in the capsule."

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a company-led drug recall for Sodium Chloride Eye Drops 5% 1x10ml (unlicensed medicine) Stockport Pharmaceuticals. Stockport Pharmaceuticals said that the above batch of Sodium Chloride Eye Drops 5% w/v as the sterile eye droppers supplied with the medicinal product have expired (Jan 2022). The authority said, "This recall is being issued as a company-led medicines recall, as this product is only supplied to a small number of customers, and the manufacturer has full traceability of the product's distribution." "Remaining stock of the above batch should be quarantined and returned to Stockport Pharmaceuticals directly."

The Medicines and Healthcare products Regulatory Agency (MHRA) has asked the pharmacies and wholesalers to stop supplying and quarantine all remaining stock of Dr Reddy's Laboratories (UK)'s Lacidipine 4 mg Film-Coated tablets. The company has recalled two batches of Lacidipine 4 mg Film-Coated tablets as a precautionary measure due to the presence of an unknown solvent-like odour. MHRA said: "The tablets are normally odourless. However, in the affected batches, a solvent-like odour is present when the individual blisters are opened. Additionally, some patient complaints have noted that the tablets have an unusual taste. The investigation to determine the root cause and to identify and quantify the odour is ongoing. "The issue is confined to batches B2202043 and B2202044 only. Other batches of Lacidipine 4 mg Film-Coated tablets marketed by Dr Reddy's Laboratories (UK) are not affected."

It has been reported that several Austrians have been taken to the hospital after injecting fake Ozempic, as confirmed by health regulator. Austria's Federal Office for Safety in Health Care (BASG) confirmed that the patients have suffered hypoglycaemia and seizures. It is believed that the injections contained insulin instead of the weight loss drug, semaglutide. The health regulator has urged doctors and patients to verify their medication stocks.