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Ticker Update

Updates

SUB-TYPE: CLASS 3 RECALL

17.03.2021

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:

PIP Code

Product Description

Supplier

Affected Batch

8073249

ITRACONAZOLE 10MG/ML ORAL SOLUTION 150ML

THAME LABORATORIES

L465

L475

1216670

ITRACONAZOLE 10MG/ML ORAL SOLUTION 150ML

THAME LABORATORIES

L465

L475

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.

SUB-TYPE: CLASS 4 CAUTION IN USE

09.03.2021

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:

 

PIP Code

Product Description

Supplier

Affected Batch

1059633

DIAZEPAM SF SOLN 2MG/5ML ACC (100ML)

ACCORD-UK LTD

I54655

I54797

I54798

I55223

I55399

I55506

I55623

I55894

I56131

I56055

I56132

1202613

DIAZEPAM SF SOLN 2MG/5ML ALM (100ML)

ALMUS

I54468

I54799

I55408

I55624

 

 

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.

SUB-TYPE: CLASS 3 RECALL

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

 

Pip code

Product description

Supplier

Batch numbers

3093465

EASYHALER SALBUTAMOL 100MCG

ORION PHARMA LTD

2009598

3093457

EASYHALER SALBUTAMOL 200MCG

ORION PHARMA LTD

2016511

 

 

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.

SUB-TYPE: FIELD SAFETY NOTICE

17.02.2021

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

 

Pip code

Product description

Supplier

Batch numbers

3673308

AQUACEL EXTRA 15CMSQ

CONVATEC LTD

0C01702

 

 

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.

SUB-TYPE: CLASS 3 RECALL

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   

Pip code

Product description

Supplier

Batch numbers

8001497

CLONIDINE HCL SF SOLN 50MCG/5ML

SYRI LTD

201014

1226778

CLONIDINE SOLN 50MCG/5ML

SYRI LTD

201014

 

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.

SUB-TYPE: CLASS 2 RECALL

CLASS 2 RECALL - MIDABUC - MIDAZOLAM (AS HCL) 10MG/ML OROMUCOSAL SOLUTION

: Eaststone Limited has informed us of an issue related to underfilled or empty bottles for MidaBuc - Midazolam (as HCL) 10mg/mL Oromucosal Solution. The below batch is being recalled as a precautionary measure following customer complaints

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-eaststone-limited-midabuc-midazolam-as-hcl-10mg-slash-ml-oromucosal-solution-el-21-a-slash-04?utm_medium=email&utm_campaign=govuk-notifications&utm_source=08ba5ead-1c0a-467b-b061-951a4cff9bb4&utm_content=immediately

Pip code

Product description

Supplier

Batch numbers

ALLIANCE DO NOT STOCK

MIDABUC - MIDAZOLAM (AS HCL) 10MG/ML OROMUCOSAL SOLUTION

EASTSTONE LIMITED

ES84553

 

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

 

Further Information

 

For more information or medical information queries please contact Eaststone at specials@eaststone.co.uk or alternatively call 0800 678 3102.

SUB-TYPE: CLASS 4 CAUTION IN USE

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

Pip code

Product description

Supplier

Batch numbers

ALLIANCE DO NOT STOCK

AMBISOME LIPOSOMAL 50 MG POWDER FOR DISPERSION FOR INFUSION

GILEAD SCIENCES LTD

019364D

D1900146D

019545D

GAD221D

020759D

019547D

D2000038D

020570D

GAD244D

020595D

D2000066D

D2000049D

 

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

SUB-TYPE: CLASS 2 RECALL

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  

Pip code

Product description

Supplier

Batch numbers

3830817

PALEXIA ORAL SOLUTION 20MG/1ML

GRUNENTHAL

PLEASE FOLLOW THE MHRA DRUG LINK

3830825

PALEXIA ORAL SOLUTION 20MG/1ML**

GRUNENTHAL

PLEASE FOLLOW THE MHRA DRUG LINK

 

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.

SUB-TYPE: CLASS 3 RECALL

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  

Pip code

Product description

Supplier

Batch numbers

0150524

KOLANTICON GEL

INTRAPHARM LABORATORIES

AC0620

 

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.

SUB-TYPE: FIELD SAFETY NOTICE

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              

Pip code

Product description

Supplier

Batch numbers

Alliance do not stock

BD Plastipak™ 1ml Luer

BD

ALL STOCK

Alliance do not stock

BD 1ml Syringe Luer-Lok™ Tip

BD

ALL STOCK

Alliance do not stock

BD Blunt Fill Needle with Filter 18G x 1 1/2 (1.2mm x 40mm) (5μm)

BD

ALL STOCK

Alliance do not stock

BD Microlance™ 3 30G x ½" 0,3 x 13mm

BD

ALL STOCK

Alliance do not stock

BD Microlance™ 3 30G x ½" 0,3 x 13mm

BD

ALL STOCK

 

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.