Ticker Update

Class 4 Drug Caution in use - AMBISOME LIPOSOMAL 50 MG POWDER FOR DISPERSION FOR INFUSION

Gilead Sciences Ltd has informed us of a quality defect issue, in relation to specific lots of 5µm sterile filters, which are co-packed in cartons of the AmBisome product. The medical device is called Minisart Filter 16534-K

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-ambisome-liposomal-50-mg-powder-for-dispersion-for-infusion-pl-16807-slash-0001-el-21-a-slash-03?utm_medium=email&utm_campaign=govuk-notifications&utm_source=b511116a-dcc6-4c20-ab3a-38f79ce58479&utm_content=immediately

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

For more information or medical information queries, please contact:

Gilead Sciences Ltd Medical Information Telephone: +44 (0) 8000 113700 E-mail: ukmedinfo@gilead.com

For stock control queries, please contact:

Customer Care direct line: +44 (0)203 681 4681 E-mail: UKCustomer.Services@gilead.com

CLASS 2 RECALL - PALEXIA ORAL SOLUTION 20MG/1ML

Grünenthal Ltd has informed us of a potential microbial contamination during routine stability testing for the batches listed in this recall. Due to the detection of possible Burkholderia contaminans the batches listed are being recalled as a precautionary measure. Burkholderia contaminans is a gram-negative bacterium and any potential infection may be more serious for immunocompromised patients and patients suffering from cystic fibrosis. This recall affects all batches of oral solution in the UK market that are still within their expiry date

This product is a Schedule 2 Controlled Drug, so please use the Returns Portal for any recalled stock you may need to return to ensure there is authorisation to return. If you are unable to use the Returns Portal please call Customer Services for assistance.

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-grunenthal-ltd-palexia-20-mg-slash-ml-oral-solution-pl-21727-slash-0054?utm_medium=email&utm_campaign=govuk-notifications&utm_source=ec81d6b3-a9c2-4242-ad66-27309a75a6fb&utm_content=immediately  

Further Information

For more information or medical information queries please contact +44 (0) 870 351 8960

medicalinformationuk@grunenthal.com

Grünenthal Ltd,1 Stokenchurch Business Park Ibstone Road HP14 3FE

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

This recall will remain open for 3 months from the date issued unless an alternative date is agreed by instigator. The closure of this will be 08/05/2021. Please note after this date customer returns may still be accepted but customers may not be credited.

CLASS 3 RECALL - KOLANTICON GEL 500ML

Intrapharm Laboratories Ltd has received a number of complaints that the product consistency is lumpy. The investigation has confirmed through review of the retained samples that the consistency of the complaint samples are similar and the retained samples for this batch show the same homogeneity issue

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-intrapharm-laboratories-ltd-kolanticon-gel-500ml-el-21-a-slash-01?utm_medium=email&utm_campaign=govuk-notifications&utm_source=1c3cadd1-c259-4e77-b3e8-c13faf584fe2&utm_content=immediately  

For more information or medical information queries, please contact: medinfo@intrapharmlabs.com or telephone +44 (0)330 1359 437.

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.

FIELD SAFTEY NOTICE - BD SYRINGES AND NEEDLES

BD has become aware that when syringes and needles are used for intraocular injections, the potential exists for “floaters” in patients’ eyes which are believed to be due to silicone. (Note: Syringes and needles manufactured by BD have silicone applied to the inside of the barrels to provide lubrication for the plunger stopper, allowing it to move easily). The potential hazard is deposition of silicone oil (SO) droplets in the vitreous.  The potential harm could be symptomatic “floaters” in the patient’s field of vision which, normally, are tolerable and resolve over a few months.  However, if sufficiently bothersome, floaters may lead to a vitrectomy for their removal

MHRA drug alert link: N/A              

This field safety notice is Advisory only so Alliance Healthcare are not accepting stock returns.

Should you have any questions or experience any issues associated with the product or issue described in this Field Safety Notice, please contact BDUKFieldAction@bd.com. BD has notified the appropriate regulatory agencies of these actions.

COMPANY-LED DRUG ALERT - RESPREEZA 1,000 MG POWDER AND SOLVENT FOR SOLUTION FOR INFUSION

CSL Behring UK Ltd is recalling the below batches of Respreeza 1,000 mg powder and solvent for solution for infusion (EU/1/15/1006/001) due to a manufacturing deviation that occurred during the filling process. There is a risk of potential microbial contamination due to the failure of the HEPA filters at the manufacturing site and the batches are being recalled as a precautionary measure. This product is only supplied to Pharmacies and/or Hospitals Pharmacies and not to wholesale, via our 3PL partner Alloga UK Ltd

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/company-led-medicines-recall-respreeza-1000-mg-powder-and-solvent-for-solution-for-infusions-eu-slash-1-slash-15-slash-1006-slash-001?utm_medium=email&utm_campaign=govuk-notifications&utm_source=ea5d64be-6beb-4a4b-b8a9-a24edc5aeea8&utm_content=immediately              

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

Company Contact for medical information enquiries

For medical information enquiries, please contact: Jo Heaton (Head of Medical Affairs UK & Ireland, Commercial Operations United Kingdom) CSL Behring UK Ltd by emailing: Jo.Heaton@cslbehring.com

Company Contact for stock enquiries

For stock information enquiries, please contact: Karien Pietersen (Head of Quality) CSL Behring UK Ltd by emailing: Karien.pietersen@cslbehring.com

CLASS 2 RECALL - Sodiofolin 50mg/ml Solution for Injection 100mg/2ml

Further to Drug Alert EL (20)A/52 issued on 11 November 2020, medac Pharma LLP is recalling further batches of products following inspection of vials showing hairline damage to the shoulder of the vials. So far, the company has not received any reports of damage for marketed products. However, as this defect may impact on the sterility of the product, the below batches are being recalled as a precautionary measure

MHRA Drug Link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-medac-gmbh-t-slash-a-medac-pharma-llp-sodiofolin-50mg-slash-ml-solution-for-injection-100mg-slash-2ml-pl-11587-slash-0005-el-20-a-slash-61?utm_source=84015acc-7689-472c-92fe-db322a8d4537&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate

Please note that Alliance Healthcare do not stock and we are not accepting stock returns.

For more information or medical information queries, please contact info@medacpharma.co.uk or telephone 01786 458086.

COMPANY-LED DRUG ALERT - INSTANYL 100MCG SINGLE DOSE

Takeda UK Limited is recalling the below batch of Instanyl 100mcg nasal spray solution (EU/1/09/531/015) due to the observation of cracked vials during inspection of the bulk vials and release testing of the finished products. So far, the company has not received any reports of damage for the marketed products. However, due to the low potential for breaking or cracking of the glass vial, which is contained within the plastic actuator casing and a potential risk of microbial contamination, the above batch is being recalled as a precautionary measure

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/company-led-medicines-recall-instanyl-100mcg-nasal-spray-solution-eu-slash-1-slash-09-slash-531-slash-015?utm_medium=email&utm_campaign=govuk-notifications&utm_source=a6ea9305-5a64-4dd6-ae86-912f9bbbe915&utm_content=immediately         

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

Company Contact for medical information enquiries

For medical information enquiries, please contact: Takeda UK Limited by emailing medinfoemea@takeda.com

Company Contact for stock enquiries

Remaining stock of these batches should be quarantined and returned to Takeda for replacement stock where available.

For stock information enquiries, please contact: Alloga UK by emailing allogaUK.credit.claims@alloga.co.uk

Company-Led drug alert Sodium Chloride 0.9% Solution For Injection

Title:  Company-Led drug alert Sodium Chloride 0.9% Solution For Injection
Class type: Company-Led drug alert

Copy: Fresenius Kabi Ltd is recalling the below batch of Sodium chloride 0.9% Solution for injection (PL 08828/0178) which has a polish labelled ampoule within some of the cartons. As this does not impact the full batch, as a precautionary measure Fresenius Kabi are recalling all packs from this batch number. The outer carton is correct and includes the correct patient information leaflet in the English language. The ampoules are the correct composition and specifications as the UK licensed material, however during manufacture the incorrect ampoule label was used. The affected batch is being recalled and all stock will be replaced by corrected stock from Fresenius Kabi Limited.

The affected products' details are as follows:

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

For stock information enquiries, please contact: Fresenius Kabi Ltd customer services centre Email: Customer.Services-UK@Fresenius-Kabi.com

Recipients of this Drug Alert should bring it to the attention of relevant contacts.

Field Safety Notice - Voluntary Recall Unisex Patterned Sock C1 Med

L&R Medical Uk Ltd (Pway)is recalling the above batches of products as a Field Safety Notice - Voluntary Recall

The affected products' details are as follows:

This is a FSN voluntary recall and Alliance will be accepting stock returns.

For further information, please contact L&R Medical on 08450 606707

Recipients of this Drug Alert should bring it to the attention of relevant contacts.

CLASS 2 RECALL - ZERBAXA 1G/0.5G POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Merck Sharp & Dohme Limited is recalling the below batches due to the presence of Ralstonia pickettii in recent batches that were manufactured. The below batches are recalled as a precautionary measure whilst investigations into the microbiological quality of the distributed products are underway

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-merck-sharp-and-dohme-limited-zerbaxa-1g-slash-0-dot-5g-powder-for-concentrate-for-solution-for-infusion-el-20-a-slash-60?utm_source=22cd61e8-ab02-4646-bc21-a8c64c009886&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate     

Please note that Alliance Healthcare do not stock and we are not accepting stock returns.

For stock control enquiries please contact customerservice.msduk@msd.com

Phone number: 01992 452094

For more information or medical information at medicalinformationuk@msd.com

Phone number: 01992 467272