Tubilux Infected Eyes Eye Drops

Class 3 Drug Alert (Action Required Within 5 Days): Bausch & Lomb (UK) Ltd - Tubilux Infected Eyes Eye Drops - Chloroamphenicl 0.5% w/v - EL (12) A/31

Baush & Lomb (UK) Ltd is recalling a batch of Tubilux Infected Eyes Eye Drops because the cartons have inadvertently been packed with the Patient Information Leaflet for Chloroamphenicol 1% w/w Eye Ointment.

Pfizer's Diflucan powder for oral suspension (10 mg/ml and 40 mg/ml)

Class 4 Drug Alert (caution in use): Diflucan powder for oral suspension (10mg/ml and 40mg/ml) -Pfizer Limited - EL (12)A/31

Pfizer Limited has recently amended the labels and Patient Information Leaflet (PIL) for the above products. They have informed the MHRA that there may be some confusion resulting from the new packaging. To ensure continuity of supply, distribution of affected stock will continue and it will be necessary to release further batches.
Steps are being taken to remedy this situation as quickly as possible, but it maybe several months before the issue is resolved.

Super Soraderm

Press release by MHRA on 14 September 2012

A Walsall man was today sentenced to nine months imprisonment, suspended for two years, on two counts of the sale, supply and possession of an unlicensed cream named ‘Super Soraderm’. The cream was marketed for use on children but it could cause some serious skin diseases.

Mohammed Rashid, aged 54, a director of a limited company, M&T Supermarkets, which has premises at 147 – 153 Caldmore Road, Wallsall, was also ordered to 200 hours of community service on each of the counts to run concurrently.

Mr Rashid was selling ‘Super Soraderm’ for £12.99 a tub and sold approximately 50 tubs every four weeks. M & T Supermarkets were fined a total of £20,000. Both were ordered to share the payment of costs of £6,944.00.

It was brought to the Medicines and Healthcare products Regulatory Agency’s (MHRA) attention by Birmingham Children’s hospital when children had become ill after parents had used ‘Super Soradem’ which contained the prescription only medicine Clobetasol Propionate - a very strong steroid that should only be prescribed by a doctor and applied sparingly.

One case involved a three-year-old boy who had developed viral warts on his body and another case involved an eight-year-old boy who had to be referred to an urgent eye clinic due to severe eczema round the eyes as a result of using the cream.

Nimo Ahmed, MHRA Acting Head of Enforcement, said “We strongly advise anyone using this product to stop immediately. Steroid based creams should only be used under the supervision of a medical professional. This is a clear example of the blatant disregard for people’s health that some will go to in order to make money.”

Professor Celia Moss, a dermatology consultant at Birmingham Children’s Hospital, who has seen first-hand the damage such strong steroids can cause to young skin, after children were treated for skin and eye problems as a result of using the cream said “People need to be aware that products being sold as ‘miracle’ treatments could contain powerful steroids. These are steroids that should only be used under medical supervision.”

AllerTek 10mg Tablets - Cetirizine dihydrochloride

Class 3 Drug Alert (Action required within five days): AllerTek 10mg Tablets - Teva UK Limited - EL (12) A/30

Teva UK Limited is recalling all remaining stock of AllerTek 10mg Tablets (cetirizine dihydrocholoride). This is because the results of dissolution tests carried out during routine stability studies did not comply with the required specification.

Diabetics to Check Hypurin Porcine Isophane Insulin Cartridges

Class 2 Drug Alert (Action required within 48 hours): Hypurin Porcine Insulin 100 IU/ml Cartridges - Wockhardt UK Ltd - EL (12) A/29

Diabetes patients are urged to check Hypurin Porcine Isophane Insulin Cartridges after packaging error identified.

Wockhardt UK Ltd has informed the Medicines and Healthcare products Regulatory Agency (MHRA) that they have received a single report of a blister from the above batch, containing 5 correctly labelled Hypurin Porcine Neutral Insulin 100 IU/ml cartridges, being inadvertently packed in a carton for Hypurin Porcine Isophane Insulin 100 IU/ml. 

Affected cartons should be quarantined and immediately reported to for return and credit or replacement to be arranged. 

Pharmacists are asked to contact patients who may have stocks of this Isophane Insulin.

The Medicinines and Healthcare products Regulatory Agency (MHRA) is today urging those with diabetes using Hypurin Porcine Isophane insulin cartridges to check their medication 

MHRA repeats warning about unlicensed tanning drug malanotan

The MHRA has repeated its warning not to use the unlicensed tanning drug melanotan.

An MHRA spokesperson said:

“We are warning people not to use this product. Melanotan is not licensed for use in the UK and there is no information about its safety. Side effects from its use could be extremely serious.

"If you have used Melanotan do not use it again and if you have any health concerns you should seek advice from your doctor.

“The sale of Melanotan is a criminal offence and we advise people who have bought this product to contact us at 020 3080 6330 or at casereferrals@mhra.gsi.gov.uk”

Cymeve 500mg Powder for Infusion

Class 2 Drug Alert (Action Required Within 48 Hours)

Cymevene 500mg Powder for Infusion - Roche Products Limited - EL (12)A/28

Roche Products Limited is recalling the above batch because there have been a small number of reports of damaged vials and there are concerns that sterility assurance cannot be guaranteed. 

Where appropriate, the product should be returned to the original supplier. Where stock was purchased from Roche Products Limited, complete stock return form and fax it back. Roche will arrange collection.

Wigmore Medical Limited

Wholesale Dealer's Licence suspended

Wigmore Medical Limited's Wholesale Dealer's licence (WL 8698) was suspended by MHRA on 16 August 2012 till 16 November 2012.

Medical Imports

Wholesale Dealer's Licence in UK

Medical Imports Wholesale Dealer's Licence (WL 20384) was suspended by MHRA from 2 August 2012 till 02 February 2013.