Ticker Update

Class 4 Drug Caution in use - SYONELL 250MG & 500MG GASTRO-RESISTANT TABLETS

: Lupin Healthcare (UK) Limited has informed us of a discrepancy with the product packaging for several batches of Syonell 250mg Gastro-Resistant Tablets and Syonell 500mg Gastro-Resistant Tablets. This discrepancy relates to the incorrect amount of active pharmaceutical ingredient (valproate semisodium) printed on the outer packaging

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-syonell-250mg-gastro-resistant-tablets-pl-35507-slash-0191-syonell-500mg-gastro-resistant-tablets-pl-35507-slash-0192-el-21-a-slash-11?utm_medium=email&utm_campaign=govuk-notifications&utm_source=58b8fb90-a905-45be-8b0f-5c608a23c4ba&utm_content=immediately

This may have been supplied by AHDL. Unfortunately we are not providing specific batch information you will  be required to follow the instructions as per the drug alert.

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

For more information or medical information queries, please contact: +44 (0) 1565 751 378 Option 1 or Pharmacovigilance Department at EU-PV@lupin.com

For stock control queries, please contact: 44 (0) 1565 751 378 Option 2 or information@lupin.com

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

Company Led - Class 2 Recall (Customer Level) SMA Wysoy Soya Infant Formula 800g

The recall of SMA Wysoy is a food safety recall due to potential presence of foreign bodies (pieces of plastic scoops). Nestlé has undertaken it on a voluntary basis.

The affected products' details are as follows:

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  

Company Led - Class 2 Recall (Customer Level) SMA Wysoy Soya Infant Formula 800g Class type: Company Led - Class 2 Recall (Customer Level)

The recall of SMA Wysoy is a food safety recall due to potential presence of foreign bodies (pieces of plastic scoops). Nestlé has undertaken it on a voluntary basis.

The affected products' details are as follows:

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  

Class 4 Drug Alert (Caution in use only) Caffeine Citrate 10mg/Ml Solution For Injection

Macarthys Laboratories Limited T/A Martindale Pharma has informed us that the EAN barcode on the outer carton of the above batch is incorrect. When scanned, the incorrect barcode shows the batch as Martindale Pharma’s Methylthioninium Chloride Injection 1% 10 X 10ml, which has been discontinued. All other information on the outer carton (including the 2D code), as well as the immediate packaging, is correct.

The affected products' details are as follows:

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

For more information or medical information queries, please contact: medinfo@ethypharm.co.uk   

For stock control queries, please contact: Alan.josiah@ethypharm.com

Field Safety Notice Cirrus2 Nebuliser, Adult, Intersurgical Ecolite Mask Kit With Tube, 2.1m, 1453015

Intersurgical Ltd have received complaints where a product that should contain an Adult EcoliteTM Aerosol Mask with vents/exhalation ports, has been found to contain a similar mask without vents/exhalation ports, this would prevent the patient breathing normally. If a mask without vents/exhalation ports is not identified and subsequently used on a patient, in situations where the patient cannot or does not remove the mask themselves this could result in distress, harm or potential fatality. It would also prevent the intended treatment being provided to the patient.

The affected products' details are as follows:

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 Field Safety Notice will remain open for 3 months from the date issued unless an alternative date is agreed by instigator. The closure of this will be 16/06/2021. Please note after this date customer returns may still be accepted but customers may not be credited.

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

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

Class 3 Recall Itraconazole 10mg/Ml Oral Solution 150ml

Thame Laboratories are recalling the above batches due to an issue with the container closure (child-resistant cap). The Marketing Authorisation Holder has received a number of complaints regarding the child-resistant caps which were difficult to open, and their investigation has identified an issue with the bottle capping process during the manufacture of the product.

The affected products' details are as follows:

For more information or medical information queries, please contact customer.services@syrimed.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.

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 15/06/2021. Please note after this date customer returns may still be accepted but customers may not be credited.

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

If you have any questions, then please contact your local service centre customer service team.

Class 4 Drug Alert Diazepam 2mg/5ml Oral Solution Sugar Free Class type: Class 4 Drug Alert (Caution in use only)

Accord-UK Ltd have informed us that important safety warnings for the excipient Propylene glycol are missing from the patient information leaflet (PIL) used in the above batches(including the batches waiting QP certification) which should be present in accordance with the current annex  to the Excipient Guidelines. Additionally, the warnings for sorbitol need updating although similar warnings are already present. The product is not subject to recall due to supply and shortage considerations

The affected products' details are as follows:

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

For more information or medical information queries, please contact:

Accord-UK Ltd Medical Information Department on 01271 385257

For stock control queries, please contact: Accord-UK Ltd Customer Services Team on 0800 373573

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

Class 3 Recall - Easyhaler Salbutamol

Orion Corporation T/A Orion Pharma (UK) Ltd are recalling the below batches as a precautionary measure due to an issue related to moulding defects in the bulk chambers where the inhalation powder is stored. There is a risk that the defect possibly presents as a hole in the bulk chamber resulting in the minor loss of inhalation powder. The manufacturer has confirmed that the devices will continue to function correctly with no impact on patient safety

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-easyhaler-salbutamol-sulfate-100-micrograms-per-actuation-slash-200-micrograms-per-actuation-inhalation-powder-el-21-a-slash-06?utm_medium=email&utm_campaign=govuk-notifications&utm_source=43302c1f-c2f7-4a15-ace9-ad4630bf5c67&utm_content=immediately

Further Information

For more information or medical information queries, please contact: UK.MedicalInformation@orionpharma.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

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 01/06/2021. Please note after this date customer returns may still be accepted but customers may not be credited.

FIELD SAFETY NOTICE - AQUACEL EXTRA 15CMSQ

ConvaTec are voluntarily initiating a field action for the below-stated product because in some instances dressing has been found attached to the seam of the primary packaging therefore breaching the sterile barrier and making the product unable to be used.  Using a non-sterile device on a patient may potentially expose the patient to infectious agents

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

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 16/05/2021. Please note after this date customer returns may still be accepted but customers may not be credited.

CLASS 3 RECALL - CLONIDINE HYDROCHLORIDE 50MICROGRAMS/5ML ORAL SOLUTION

SyriMed are recalling the below batch as a precautionary measure due to an issue related to the container closure (child-lock cap). The Marketing Authorisation Holder has received a number of complaints related to defective container closures and the investigation has identified an issue with the bottle capping during the manufacturing process for this batch only

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-syrimed-clonidine-hydrochloride-50micrograms-slash-5ml-oral-solution-el-21-a-slash-05?utm_medium=email&utm_campaign=govuk-notifications&utm_source=9d29e170-51bd-475e-b98c-3e284cb06be1&utm_content=immediately   

Further Information

For more information or medical information queries, please contact: customer.services@syrimed.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

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 16/05/2021. Please note after this date customer returns may still be accepted but customers may not be credited.