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 Medicine and Healthcare Product Regulatory Agency (MHRA) has recalled all pholcodine-containing medicines from the UK pharmacy due to concerns of its
potential to cause a severe allergic reaction in some people having general anaesthesia for surgery.
The decision was made following the conclusion of a review of post-marketing safety data by the MHRA. The Commission on Human Medicines (CHM) has considered the
evidence of an increased risk of the very rare event of anaphylaxis when exposed to neuromuscular blocking agents (NMBA) and advised that pholcodine-containing
medicines should be withdrawn.
MHRA has advised pharmacists to consider recommending appropriate treatment alternatives for patients who present with a new dry cough or who are currently taking
pholcodine.
Royal Pharmaceutical Society (RPS) President Professor Claire Anderson said: "If you are taking a cough medicine (including tablets and syrups), check the packaging,
label or Patient Information Leaflet to see if pholcodine is a listed ingredient - if it is, and you have any questions, you can talk to your pharmacist who can
suggest a different medicine suitable for you.
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 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.
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.
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."
Kent Pharma UK has announced a precautionary recall of multiple batches of Itraconazole 10mg/ml oral solution following the identification of
out-of-specification appearance in the solution, particularly the presence of suspended particles or clusters of crystals.
Itraconazole is an antifungal medication prescribed for treating fungal or yeast infections in different parts of the body. Its oral solution form is
specifically intended for treating oropharyngeal or esophageal candidiasis, commonly known as thrush or oral thrush.
The Medicines and Healthcare products Regulatory Agency (MHRA) has advised the recall following initial investigations, which indicated a solubilisation
issue of the active ingredient, itraconazole.
This problem may result in some doses containing lower amounts of the active ingredient.
The root cause of the issue is currently under investigation. However, due to the potential for underdosage, the affected batches are being recalled as a
precautionary measure.
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 cautioned people to stop using certain eye gels, highlighting a potential risk of
microbial contamination that can cause an infection.
As a precaution, the agency on Friday announced recall of specific batches of carbomer-containing lubricating eye gels branded Aacarb, Aacomer and Puroptics,
which are generally used to relieve the symptoms of dry eye.
Burkholderia cenocepacia is suspected to have caused the microbial contamination, and the issue was raised after an ongoing investigation conducted by UK Health
Security Agency (UKHSA) identified a small number of cases of infection.
Investigations are on to determine if there is a link between these products and the infections which have been identified.
Meanwhile, retailers have been told to withdraw the affected products, and users are asked to return their product to the place of purchase immediately.
Supply of all Champix products, used for smoking cessation, will remain out of stock until further notice from the Medicines and Healthcare products Regulatory
Agency (MHRA).
The announcement follows a medicine recall order initiated by the MHRA for "all strengths of Champix® tablets" on October 14, 2021 at pharmacy and wholesaler level.
Pfizer, the sole supplier of Champix tablets, stopped the distribution of 0.5mg and 1mg tablets in early June 2021.
The company is currently unable to confirm when supplies will resume amid global regulatory investigations relating to the presence of nitrosamine impurities above
the Pfizer's acceptable level of daily intake in several lots.
The Medicines and Healthcare products Regulatory Agency (MHRA) has advised healthcare professionals to stop supplying a specific batch of Paroxetine 40mg Film Coated Tablets immediately.
Crescent Pharma Limited is recalling a specific batch of Paroxetine 40mg Film Coated Tablets as a precautionary measure due to out of specification results for dissolution during routine stability testing.
"Quarantine all remaining stock of the said batch and return it to your supplier, using your supplier's approved process," said MHRA.
The agency alerted the patients that this is a precautionary Pharmacy and Wholesaler level recall, therefore no further action is required by patients.
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."
The Medicines and Healthcare products Regulatory Agency has issued a class 2 medicines recall notice for Olopatadine USV 1mg/ml eye drops.
Specific batches of this product are being recalled by USV UK Limited as a precautionary measure due to the identification of out of specification results for impurities during routine stability testing.
USV UK Limited are recalling the affected batches as a precautionary measure due to out of specification results for impurities during routine stability testing.
The Medicines and Health products Regulatory Agency (MHRA) on Thursday issued a class 4 medicines defect information notice for Cozaar 100mg film-coated
tablets due to an error in the Patient Information Leaflets (PILs) reported by the company.
Cozaar is used to treat high blood pressure (hypertension) as well as to slow the progression of kidney disease in people who have type 2 diabetes mellitus.
Quadrant Pharmaceuticals Ltd has informed the UK regulatory authority that the PILs that have been packed in certain batches of the products do not have the most
up to date safety information.
'Grapefruit juice should be avoided while taking Cozaar'- This information is missing in Section 2 'What you need to know before you take Cozaar', sub section
'Cozaar with food and drink', the company clarified.
In the pharmaceutical industry, maintaining high standards for water quality is crucial for ensuring product safety, efficacy, and compliance with
regulatory standards.
Water is a fundamental ingredient in drug manufacturing, and its quality directly impacts the production process and the end products. This makes adherence
to water service compliance a legal obligation and a critical aspect of operational integrity.
THE LEGAL COMPLICATIONS OF POOR WATER QUALITY
Compliance with water quality standards in the pharmaceutical industry is mandated by regulatory agencies such as the MHRA, several regulations that set
strict criteria for the types of water used, including purified water, water for injection, and sterile water.
Failure to meet these standards can result in severe penalties, including product recalls, fines, and loss of manufacturing licenses. Regulatory compliance
ensures the pharmaceutical companies adhere to legislations and avoid legal repercussions that can damage their reputation and financial standing
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.