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SUB-TYPE: COMPANY-LED RECALL

Company Led Drug Alert Optiray 300mg & 350mg I-Ml Solution For Injection Class type: Company Led

Guerbet Laboratories Limited is recalling the above batches of products as a precautionary measure due to reports received from healthcare professionals on the difficulties in attaching the Luer lock adapter to the Luer tip of the pre-filled syringe and tubing catheter. In some cases this has resulted in leakages of contrast media during use.

 

The affected products' details are as follows:

PIP Code

Product Description

Supplier

Affected Batch

ALLIANCE DO NOT STOCK

Optiray 300mg I/ml Solution for Injection or Infusion

Guerbet Laboratories Limited

20H1482U

20H1452U

20F1342U

20F1312U

20F1292U

ALLIANCE DO NOT STOCK

Optiray 350mg I/ml Solution for Injection or Infusion

Guerbet Laboratories Limited

20H1482U

20H1452U

20F1342U

20F1312U

20F1292U

 

Alliance do not stock these products and therefore we are not accepting stock returns.



For medical information and stock enquiries, please contact Guertbet Laboratories Limited on Tel: 01217338542

 

E-mail (medical enquiries): uk.sales@guerbet.com and Krupa.mehta@guerbet.com

 

Email (stock enquiries): uk.sales@guerbet.com

 

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

SUB-TYPE: FIELD SAFETY NOTICE

Field Safety Notice Activheal® Hydrogel 8g

AMS has identified that due to a tube quality issue that was determined during the manufacturing process, the sterility of a small number of the Affected Tubes may have been compromised. Investigations have determined a potential root cause and AMS are confident that the quality issue only affects the Affected Tubes and is not present in other batches of the ACTIVHEAL® Hydrogel product

 

The affected products' details are as follows:

PIP Code

Product Description

Supplier

Affected Batch

3779956

ACTIVHEAL® HYDROGEL 8G

ADVANCED MEDICAL SOLUTIONS

43783

45556

 

This is an NWOS only recall and Alliance will not be accepting stock returns. Please contact Advanced Medical Solutions for further information

For further information regarding this Field Safety Notice Please contact Teresa Starkey at Advanced Medical Solutions. Email: Teresa.starkey@admedsol.com Tel: +441606 545617

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

SUB-TYPE: CLASS 2 RECALL

Class 2 Recall on Epilim 500mg Ec Tabs

Sanofi is recalling the above batches of product as a precautionary measure due to out of specification results for disintegration test during routine stability testing.

 

Please visit the: MHRA website for more details on this drug alert.

 

The affected products' details are as follows:

PIP CodeProduct DescriptionSupplierAffected Batch
4093118EPILIM 500MG EC TABSSANOFIR0601
R0602
R0603

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

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

For medical information enquiries please contact uk-medicalinformation@sanofi.com or call 0800 035 25 25

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

 

Please return any affected stock to your original supplier for credit.

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

SUB-TYPE: CLASS 3 RECALL

Class 3 Recall on Metoprolol 50 Mg Tablets

Accord Healthcare Ltd has informed us of an issue related to decommissioning of the above batches. Upon decommissioning at the pharmacy, there have been reports stating that when scanning the serialised 2D code, the status of packs may report as ‘EXPORT.' Although there is no risk to product quality, any remaining stock should be quarantined and returned.

 

Please visit the: MHRA website for more details on this drug alert.

 

The affected products' details are as follows:

PIP CodeProduct DescriptionLiveryAffected Batch
1156090METOPROLOL TAB 50MGACCORDP2000978
P2000285
1128289METOPROLOL TAB 50MGACCORDP2000978
P2000285
1079466METOPROLOL TAB 50MGACCORDP2000978
P2000285
1178896METOPROLOL TAB 50MGACCORDP2000978
P2000285

For stock control enquiries please contact Accord-UK Ltd Customer Services Team on 0800 373573.

For medical information enquiries please contact Accord-UK Ltd Medical Information Department on 01271 385257.

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

 

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: CLASS 2 RECALL

Class 2 Recall on Boots Dermacare 1% W/W Hydrocortisone Ointment (P)

The Boots Company PLC has informed us that retained samples of the affected batch showed presence of Pseudomonas aeruginosa and are recalling the above batch as a precautionary measure. This product is only sold or dispensed from Boots stores and Boots online pharmacy.

 

Please visit the: MHRA website for more details on this drug alert.

 

The affected products' details are as follows:

PIP CodeProduct DescriptionSupplierAffected Batch
ALLIANCE DO NOT STOCKBOOTS DERMACARE 1% W/W HYDROCORTISONE OINTMENT (P)THE BOOTS COMPANY PLC1DD

Please note that Alliance do not stock the above product therefore we are not accepting returns on this recall.

For stock control and medical information enquiries please contact 0115 9595165.

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.

SUB-TYPE: CLASS 2 RECALL

Class 2 FMD Recall on Vimpat 100mg Tablets & Neupro 4mg/24 Hour Transdermal Patches

We have been notified of an issue whereby several affected batches of the products from the parallel distributors (repackers) in the link below have been found to have mismatched unique pack numbers on the Bollino label (a security and safety feature on the outer packaging). The unique pack numbers on the bollino label should be identical.

 

Please visit the: MHRA website for more details on this drug alert.

 

The affected products' details are as follows:

.
PIP CodeProduct DescriptionSupplierAffected Batch
8386492PI VIMPAT TAB 100MGVARIOUS, PLEASE REFER TO THE ABOVE LINKVARIOUS, PLEASE REFER TO THE ABOVE LINK
8121238PI NEUPRO PATCHES 4MGVARIOUS, PLEASE REFER TO THE ABOVE LINKVARIOUS, PLEASE REFER TO THE ABOVE LINK
8449324PI VIMPAT TAB 100MGVARIOUS, PLEASE REFER TO THE ABOVE LINKVARIOUS, PLEASE REFER TO THE ABOVE LINK

Further Information BeachCourse Limited For all enquiries please contact:

Julio Iglesias (Site Manager) on 02088969075 or email at julio.bcourse@btconnect.com.

Orifarm A/S For all enquiries please contact:

Paul Tobin (Responsible Person) on 07583577513 or email at paul.tobin@orifarm.com.
Steven Cross (UK Parallel Import Sales Manager) on 07498975920 or email at steven.cross@orifarm.com.

OPD Laboratories Limited For all enquiries please contact:
Vasanth Samson (Quality Assurance Manager/Responsible Person) on 01923332773 or email at vasanth@sigmapl.com.

Strathclyde Pharmaceuticals Limited For all enquiries please contact:
Derek Cochrane (QA Manager) at dcochrane@munro-group.eu.

Quadrant Pharmaceuticals Limited For all enquiries please contact:
Abdul Butt (Director, Quality & QP) on 07838038063 or email at abdul.butt@maxearn.co.uk.


Lexon (UK) Limited For all enquiries please contact:
Yogesh Patel at yogesh.patel@lexonuk.com

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

 

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 1 month Please note after this date customer returns may still be accepted but customers may not be credited.

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

SUB-TYPE: CLASS 4 CAUTION IN USE

Class 4 Caution in Use on Zopiclone 3.75mg & 7.5mg Tablets

Ratiopharm UK Limited and Generics [UK] Limited t/a Mylan have confirmed that the Patient Information Leaflet (PIL) within all packs and the Summary of Product Characteristics (SmPC) for Ratiopharm is missing important safety information related to potential suicide risks.

 

Please visit the: MHRA website for more details on this drug alert.

 

The affected products' details are as follows:

PIP CodeProduct DescriptionLiveryAffected Batch

1110980ZOPICLONE TAB 3.75MGRatiopharm UK Limited and Generics [UK] Limited t/a MylanALL STOCK

1073626ZOPICLONE TAB 3.75MGRatiopharm UK Limited and Generics [UK] Limited t/a MylanALL STOCK

1076074ZOPICLONE TAB 3.75MGRatiopharm UK Limited and Generics [UK] Limited t/a MylanALL STOCK

1073584ZOPICLONE TAB 7.5MGGenerics [UK] Limited t/a MylanALL STOCK

1110998ZOPICLONE TAB 7.5MGGenerics [UK] Limited t/a MylanALL STOCK

1073618ZOPICLONE TAB 7.5MGGenerics [UK] Limited t/a MylanALL STOCK

8094740ZOPICLONE TAB 3.75MGRatiopharm UK Limited and Generics [UK] Limited t/a MylanALL STOCK

8094757ZOPICLONE TAB 7.5MGGenerics [UK] Limited t/a MylanALL STOCK

For more information or medical information queries, please contact: Ratiopharm UK Limited Teva UK Medical Information at: medinfo@tevauk.com or Tel No: 0207 540 7117

Generics [UK] Limited t/a Mylan Medical Information Direct Line +44 (0)1707 853 000 select option 1, Customer Care direct lin+44 (0)1707 853 000 select option 2 or via Medical Information e-mail info@mylan.co.uk

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

 

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.

 

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

SUB-TYPE: CLASS 3 RECALL

Class 3 Recall on Amlodipine 10mg Tablets

Accord Healthcare Limited is recalling the below batch of Amlodipine 10mg Tablets as a precautionary measure due to out of specification results for tablet description, hardness and average weight obtained during stability testing.

 

Please visit the: MHRA website for more details on this drug alert.

 

The affected products' details are as follows:

PIP CodeProduct DescriptionSupplierAffected Batch
1178177AMLODIPINE TAB 10MGACCORDGY0128
1117969AMLODIPINE TAB 10MGACCORDGY0128
1136175AMLODIPINE TAB 10MGACCORDGY0128
1143353AMLODIPINE TAB 10MGACCORDGY0128
8142705AMLODIPINE TAB 10MGACCORDGY0128

Accord-UK Ltd Medical Information Department Tel: 01271 385257 Email: medinfo@accord-healthcare.com

For stock control enquiries please contact: Accord-UK Ltd Customer Services Team Tel: 0800 373 573

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

 

Please note that Alliance have not supplied the affected batch therefore we are not accepting returns on this recall.

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

SUB-TYPE: CLASS 4 CAUTION IN USE

Class 4 FMD Recall Various products

The MHRA is currently investigating an incident where several medicines appear to have left the legal supply chain and have then been re-introduced via Kingsley Specials Ltd WDA(H) 49276, who purchased from a company that does not hold a wholesale dealers authorisation and then sold it on to a number of other wholesalers.

 

Please visit the: MHRA website for more details on this drug alert.

 

The affected products' details are as follows:

PIP CodeProduct DescriptionSupplierAffected Batch
6839229Pi Eliquis Tabs 2.5mg 60Drugsrus LtdABF5980
ABF6042
ABG1454
ABG1455
ABG1774
ABG1777
ABH0620
ABH0984
ABH4133
ABH4337
ABH4340
ABJ8246
ABJ8737
Alliance have not suppliedEliquis 5 mg film-coated tabletsPlease refer to attached documentPlease refer to attached document
Alliance have not suppliedEntyvio 300 mg powder for concentrate for solution for infusionPlease refer to attached documentPlease refer to attached document
Alliance have not suppliedFlutiform 250 microgram/10 microgram per actuation pressurised inhalation, suspensionPlease refer to attached documentPlease refer to attached document
Alliance have not suppliedPrivigen 20 g - 100 mg/ml solution for infusionPlease refer to attached documentPlease refer to attached document
Alliance have not suppliedSeretide Evohaler 25 microgram/125 microgram per metered dose pressurised inhalation, suspensionPlease refer to attached documentPlease refer to attached document
Alliance have not suppliedSeretide Evohaler 25 microgram/250 microgram per metered dose pressurised inhalation, suspensionPlease refer to attached documentPlease refer to attached document
Alliance have not suppliedStelara 45 mg solution for injection in pre-filled syringePlease refer to attached documentPlease refer to attached document
Alliance have not suppliedStelara 90 mg solution for injection in pre-filled syringePlease refer to attached documentPlease refer to attached document
Alliance have not suppliedStelara 130 mg concentrate for solution for infusionPlease refer to attached documentPlease refer to attached document
Alliance have not suppliedSymbicort® Turbohaler® 200 micrograms/6micrograms inhalation, inhalation powderPlease refer to attached documentPlease refer to attached document
Alliance have not suppliedSynagis 100 mg/1 ml solution for injectionPlease refer to attached documentPlease refer to attached document
Alliance have not suppliedTysabri 300 mg concentrate for solution for infusionPlease refer to attached documentPlease refer to attached document
Alliance have not suppliedZebinix 800mg tabletsPlease refer to attached documentPlease refer to attached document

We will only be accepting Stock returns on PIP 6839229 Pi Eliquis Tabs 2.5mg 60 we are only able to accept stock back that is inactive or stolen stock.

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 contacts for further information Smartway Pharmaceuticals Limited • Email: regulatory@smartwaypharma.co.uk • Telephone: 020 8545 7743 Drugsrus Limited • Email: recall@drugsrus.co.uk • Telephone: 020 3397 2347 Optimal Pharma Limited • Email: info@optimalpharma.co.uk • Telephone: 020 3884 0032

 

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

SUB-TYPE: CLASS 2 RECALL

Class 2 Recall on Oxylan 40mg prolonged-release tablets

GL Pharma is recalling the above batch of Oxylan 40mg prolonged-release tablets due to out of specification results for dissolution obtained during routine stability testing.

 

Please visit the: MHRA website for more details on this drug alert.

 

The affected products' details are as follows:

PIP CodeProduct DescriptionLiveryAffected Batch
6359830OXYCODONE (OXYLAN) PR TAB 40MGGL PHARMA9F119A
3726148OXYCODONE PR TAB 40MG CHANGL PHARMA9F119A

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 then your Alliance Healthcare driver will have a ‘Specialist Product Recall Book' with them on Wednesday 2nd September and Thursday 3rd September for completion and product uplift AM ONLY. Due to Covid 19, the driver will complete the form on your behalf. They will ask for the quantity of stock you have to return and the name of the pharmacist. The driver will give you a copy of the completed form for your records. If you need to return recalled stock from 4th September and are unable to use the Returns Portal please call Customer Services for authorisation to return.

Further Information

For medical information enquiries please contact pv@gl-pharma.at

For stock control enquiries please contact david.hammond@healthcarepharma.co.uk

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

 

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.