CLASS 2 RECALL - IKERVIS EYE DROPS 0.1%

SANTEN Oy (trading as Santen UK Limited) are recalling the below batch of products as a precautionary measure due to detection of particles/crystals of the active pharmaceutical ingredient ciclosporin. These particles have been detected following microscopic evaluation during stability monitoring.

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-santen-oy-trading-as-santen-uk-limited-ikervis-1-mg-slash-ml-eye-drops-emulsion-el-22-a-slash-01?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=9afe2758-9d36-4cbd-86c2-bef85307f4a5&utm_content=immediately     

Alliance do not stock the above products so we will not be accepting Customer returns on this recall.

Further Information

Santen UK Limited

For more information, please contact +44 (0)1727 615 110 or email enquiries@santen.co.uk

For medical information queries, please contact 0345 075 4863 or email medinfo@santen.co.uk

For supply queries, please contact AAH Customer services at 0344 561 8899

If you have any questions, then please contact your local Service Centre Customer Services team.

Company Led Recall - Dermaved Sensitive Cream (Unlicensed Medicine)

Dermaved is recalling the above product from patients due to presence of clobetasol propionate (0.001% w/w). This product is supplied by Dermaved online.

The company’s investigation is on-going. Remaining stock of the above product should be returned to the company directly.

Clobetasol propionate is a strong steroid and it is an active ingredient in Prescription Only Medicines used for the treatment skin conditions such as psoriasis and eczema. Creams containing steroids should be used sparingly and as directed by the prescriber.

Although the presence of clobetasol propionate in this product is low, patients are advised to stop using the cream immediately, particularly pregnant and breastfeeding women, babies and young children.

There have been infrequent cases of skin reactions after stopping the use of creams containing steroids. Patients are advised to consult a doctor if their skin worsens within 2 weeks of stopping this cream or if they experience any side-effects from using this product. Suspected side effects should also be reported via the Yellow Card Scheme.

MHRA drug alert link: https://www.alliance-healthcare.co.uk/alliance-healthcare-news-updates?field_category_target_id=161 

Alliance do not stock this product and therefore we are not accepting stock returns.

Company contact for enquiries:

For more information, please contact Dermaved: info@dermaved.com

If you have any questions, then please contact your local Service Centre Customer Services team.

Class 4 Drug (Caution in use) - Benylin Chesty Coughs Original and Benylin Chesty Coughs Non-Drowsy

McNeil Products Limited have identified an error relating to the stated alcohol content for batches of Benylin Chesty Coughs Original (P) and Benylin Chesty Coughs Non-Drowsy (GSL) whereby the product labels understate the ethanol values. The products comply with the defined specifications, including ethanol content and, other than the incorrect ethanol content, all other label information is correct. However, the amount of ethanol contained within the products is low and hence the related on-pack safety warning, which reads “The small amount of alcohol in this medicine will not have any noticeable effects.”, is correct.

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-benylin-chesty-coughs-original-p-and-benylin-chesty-coughs-non-drowsy-gsl-el-21-a-slash-39?utm_medium=email&utm_campaign=govuk-notifications&utm_source=d42e0844-42e5-46ca-8471-2a82d76c7a4a&utm_content=immediately

This is a caution in use only we are not accepting stock returns.

Further Information:
For medical information queries please contact: McNeil Products Limited on 1344 864042 or by email to crc@its.jnj.com

Class 2 Recall - Heparin sodium 1,000 i.u./ml solution for injection or concentrate for solution for infusion

Wockhardt UK Ltd is recalling the above batch as a precautionary measure due to out of specification results due to a low bioassay result at the 24-month shelf life stability testing.

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-wockhardt-uk-ltd-heparin-sodium-1000-i-dot-u-slash-ml-solution-for-injection-or-concentrate-for-solution-for-infusion-el-21-a-slash-38?utm_medium=email&utm_campaign=govuk-notifications&utm_source=8c88aa6c-3295-4d61-b6ac-4b16836ec2d6&utm_content=immediately

Further Information

For more information or medical information queries, please contact: drug.safety@wockhardt.co.uk

For stock control queries, please contact: customer.services@wockhardt.co.uk

Please return all affected stock to your original supplier for credit. Unfortunately we can only accept stock purchased from us (Alliance Healthcare Distribution Limited). Any other stock will be returned to your stores/Pharmacies.

Please note that anything not returned to us, or notified to us, within 3 months of this notification, cannot be reimbursed by way of a credit.

If you have any questions, then please contact your local Service Centre Customer Services team.

Class 4 Drug (Caution in use) - SmofKabiven Central emulsion for Infusion

Fresenius Kabi Limited have identified an error on the infusion bag packaged into the above batches. In the energy content section printed onto the bag the amount of carbohydrates (glucose anhydrous) has been incorrectly declared as 150g, the actual amount is 125g.

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-smofkabiven-central-emulsion-for-infusion-fresenius-kabi-ltd-el-21-a-slash-37?utm_medium=email&utm_campaign=govuk-notifications&utm_source=5a6a839e-bd5e-40f6-92dd-6c73adf4498f&utm_content=immediately   

This is a caution in use only we are not accepting stock returns.

Further Information

For more information or medical information queries please contact:

Medical.Information-UK@fresenius-kabi.com

If you have any questions, please contact your local Service Centre Customer Services team.

Company Led Recall - VITAMIN D3 DROPS

A quality issue has recently been identified in relation to the dispensing method used in the Vitamin D3 Drops for infants

MHRA drug alert link: N/A   

Please return all affected stock to your original supplier for credit. Unfortunately we can only accept stock purchased from us (Alliance Healthcare Distribution Limited). Any other stock will be returned to your stores/Pharmacies

Please note that anything not returned to us, or notified to us, within 3 months of this notification, cannot be reimbursed by way of a credit.

If you have any questions, then please contact your local Service Centre Customer Services team.

CLASS 2 RECALL - MYDRILATE EY/D 0.5%

Intrapharm Laboratories Ltd are recalling the below batch of Mydrilate 0.5 % Eye Drops 5ml as a precautionary measure due to out of specification results for related substances obtained during stability testing

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-intrapharm-laboratories-ltd-mydrilate-0-dot-5-percent-eye-drops-5ml-el-21-a-slash-35?utm_medium=email&utm_campaign=govuk-notifications&utm_source=ae9c5b07-b1e0-4f64-bd26-24f1907b748f&utm_content=immediately

Further Information

For more information or medical information queries, please contact: Redline Pharmacovigilance, email: medinfo@intrapharmlabs.com, Contact number: 0330 1359 437

For stock control queries, please contact: Lauren Johnson, Commercial Affairs Manager, Intrapharm Laboratories Ltd, email: Lauren.Johnson@riemser.com; Landline: 01628 771800.

Please return all affected stock to your original supplier for credit. Unfortunately we can only accept stock purchased from us (Alliance Healthcare Distribution Limited). Any other stock will be returned to your stores/Pharmacies.

Please note that anything not returned to us, or notified to us, within 3 months of this notification, cannot be reimbursed by way of a credit.

If you have any questions, then please contact your local Service Centre Customer Services team.

CLASS 2 RECALL - VARIOUS MARKETING AUTHORISATION HOLDERS AND PARALLEL DISTRIBUTOR COMPANIES

Important update:

Further to the recall below, the MHRA have sent an updated version with the below changes.

Change made:

Batch ET042/2156 has been added to BR Lewis Pharmaceuticals, 150mg Aprovel section (this batch number has been added in the table below).

Updated link:

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-various-marketing-authorisation-holders-and-parallel-distributor-companies-irbesartan-containing-products-el-21-a-slash-34?utm_medium=email&utm_campaign=govuk-notifications&utm_source=51215d28-2f33-4366-a0f9-0eb7cd46f26b&utm_content=immediately

Specific batches of the below products are recalled by the Marketing Authorisation Holders and parallel distributor companies as a precautionary measure due to contamination with an impurity called 5-(4’-(azidomethyl)-[1,1’-biphenyl]-2yl)-1H-tetrazole, which has mutagenic potential. These batches are being recalled as the level of contamination is above the acceptable limit

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-various-marketing-authorisation-holders-and-parallel-distributor-companies-irbesartan-containing-products-el-21-a-slash-34?utm_medium=email&utm_campaign=govuk-notifications&utm_source=1bddc3b6-a77c-46a3-9a16-7732942ac3dc&utm_content=immediately   

Aventis Pharma Limited T/A Sanofi

Parallel Distributors

Chemilines Ltd

Drugsrus Ltd (Repackaged by P.I.E Pharma Ltd)

Lexon (UK) Ltd

BR Lewis Pharmaceuticals Ltd (Repackaged by Doncaster Pharmaceuticals Group Ltd)

Gowrie Laxmico Ltd T/A B&S Healthcare

Quadrant Pharmaceuticals Ltd (Repackaged by Maxearn Ltd)

OPD Laboratories Ltd

Further Information

Sanofi

For stock control enquiries, please contact GB-CustomerServices@sanofi.com or 0800 854 430.

For more information or medical information queries, please contact uk-medicalinformation@sanofi.com or 0800 035 2525.

Chemilines

For more information or medical information queries, please contact Ashutosh Pradhan at Ashutosh.pradhan@chemilines.com.

For supply queries, please contact Nisha Brar at Nisha.brar@chemilines.com.

BR Lewis Pharmaceuticals Ltd / Doncaster Pharmaceuticals Group Ltd

For more information or medical information queries, please contact Richard Gore at 01302 554805 or Richard.gore@doncaster-pharm.com.

For supply queries, please contact Rebecca Platts at 01302 552961 (Mon-Fri 8am-4pm) or rebecca.platts@doncaster-pharm.com.

Drugsrus Ltd

For more information or medical information / supply queries, please contact Drugsrus Limited at recall@drugsrus.co.uk or 0208 423 3800.

Lexon (UK) Ltd

For more information or medical information queries, please contact Yogesh Patel at yogesh.patel@lexonuk.com or 07515 765513.

For supply queries, please contact Heather Jordan at heather.jordan@lexonuk.com.

Gowrie Laxmico Ltd T/A B&S Healthcare

For more information or medical information queries, please contact medinfo@bnsheathcare.com or 0800 049 9401 ext 941.

For supply queries, please contact customerservice@bnshealthcare.com.

Quadrant Pharmaceuticals Ltd

For all enquiries please contact Radoslaw Bandomir at radoslaw.bandomir@maxearn.co.uk.

OPD Laboratories Ltd

For more information or medical information queries, please contact Sasi Vimalaranjithan / Hemang Patel at 01923 332 796 or sasi@sigmaplc.com / hemang@sigmaplc.com.

For supply queries, please contact Vasanth Samson / Krina Shah at qa@sigmaplc.com.

Please return all affected stock to your original supplier for credit. Unfortunately we can only accept stock purchased from us (Alliance Healthcare Distribution Limited). Any other stock will be returned to your stores/Pharmacies.

If you have any questions, then please contact your local Service Centre Customer Services team.

Class 4 Drug Caution in use - MOMETASONE FUROATE 50 MICROGRAM / DOSE NASAL SPRAY, SUSPENSION

PilsCo Ltd. have identified a error relating to the wording on the outer carton label. The label affixed on the bottle states: ‘use within 2 weeks of first use’, instead of the correct label statement which should be: ‘use within 2 months of first use

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-mometasone-furoate-50-microgram-slash-dose-nasal-spray-suspension-pilsco-ltd-el-21-a-slash-33?utm_medium=email&utm_campaign=govuk-notifications&utm_source=e049222e-87bd-466b-af5c-870967570da8&utm_content=immediately    

This is a caution in use only we are not accepting stock returns.

Further Information

For more information, medical information queries or stock control queries, please contact: Nigel Kelly Nigel@ethigen.co.uk 013555 98155

If you have any questions, then please contact your local Service Centre Customer Services team.

CLASS 3 RECALL - METHADONE TAB 5MG (PHYSEPTONE 5MG TABLETS)

Martindale Pharma is recalling the below batch of Methadone 5mg tablets as a precautionary measure due to the discolouration of the PVdC film in a small number of blister pockets

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-martindale-pharma-an-ethypharm-group-company-methadone-5mg-tablets-slash-physeptone-5mg-tablets-el-21-a-slash-31?utm_medium=email&utm_campaign=govuk-notifications&utm_source=c480fd76-d520-4a64-9570-f410b38c7b35&utm_content=immediately   

Further Information

For more information please contact:

Customer Services for stock control enquiries: Licensed@ethypharm.com

or for Medical Information enquiries: medinfo@martindalepharma.co.uk

Please return all affected stock to your original supplier for credit. Unfortunately we can only accept stock purchased from us (Alliance Healthcare Distribution Limited). Any other stock will be returned to your stores/Pharmacies.

Please note that anything not returned to us, or notified to us, within 3 months of this notification, cannot be reimbursed by way of a credit.

If you have any questions, then please contact your local Service Centre Customer Services team.