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Updates

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.

SUB-TYPE: CLASS 2 RECALL

Class 2 Recall on Fasturtec® 7.5 mg. 1.5 mg/ml

Sanofi has informed us of an Out Of Specification (OOS) result which was detected for Rasburicase enzyme activity according to a specific method and specifications for US market, at 12 months stability time point. Sanofi is recalling Fasturtec® 7.5 mg (Rasburicase) Solution for IV infusion - 7.5 mg/5 ml (Injectable powder in vial packaged with 5 ml solvent in ampoule), batch number A9306 as a precautionary measure.

 

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

 

The affected products' details are as follows:

PIP CodeProduct DescriptionSupplierAffected Batch
3338928Fasturtec® 7.5 mg. 1.5 mg/ml powder and solvent for concentrate for solution for infusionSanofiA9306

For medical information enquiries please contact uk-medicalinformation@sanofi.com Med Info Phone :0800 035 25 25.

For stock control enquiries please contact GB-CustomerServices@sanofi.com Phone number: 0800 854 430

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

 

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

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 SmofKabiven extra Nitrogen Electrolyte Free

Fresenius Kabi Ltd & Calea UK Ltd has informed us of an error on the bag labels for SmofKabiven extra nitrogen electrolyte free, emulsion for infusion PL 08828/0269. A sentence has been inadvertently included stating "with electrolytes" on an electrolyte free product. The outer cartons and leaflets have been checked and these are all in compliance. The bag label should state "1. Amino acid solution.

 

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 stockSmofKabiven extra Nitrogen Electrolyte FreeFresenius Kabi Ltd & Calea UK Ltd10NI3300
10PB8836

Alliance healthcare do not stock this product and as this is a caution in use only we are not accepting stock returns.

For more information or medical information queries, please contact: Medical.Information-UK@fresenius-kabi.com

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 Phosphates Solution For Infusion 500ml

Huddersfield Pharmacy Specials (HPS) is recalling the above batches of phosphates solution for infusion due to observation of precipitation in batch 500609X. The decision to recall all other batches has been made as a precautionary measure.

 

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 stockPhosphates Solution For Infusion 500mlHuddersfield Pharmacy Specials (HPS)Please follow the above link

Alliance Healthcare do not stock this line therefore we will not be accepting customer returns.

For stock control queries please contact: HPS Customer Services, 01484 355388.

For any medical information enquires please contact: Dr Burrinder Grewal, 01484 355230.

 

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 Clexane 4,000 Iu (40mg) /0.4ml Syringes

Pharmaram Ltd has informed us that the below batch of Clexane 4,000IU (40mg)/0.4ml syringes has an error on the labelling affixed to the plastic blister packaging encasing the syringe. The label incorrectly states "Clexane 6,000IU (60mg)/0.6ml Syringes", when it should have stated "Clexane 4,000IU (40mg)/0.4ml Syringes". The outer carton states the correct strength; the batch number and expiry dates are also correct and match the details on the labelling.

 

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

 

The affected products' details are as follows:

PIP CodeProduct DescriptionSupplierAffected Batch
8129165PI CLEXANE PFS 40MGPHARMARAM LTDCCL67G/D3

For stock control queries please contact:Pharmaram Ltd Austin Chambers Email: austin@dixpharm.com Tel: +44 (0) 1530 410920 Mob: +44 (0) 7944 664400

For any medical information enquires please contact: Pharmaram Ltd Email: quality@dixpharm.com Tel: +44 (0) 1530 410920

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 4 CAUTION IN USE

Class 4 Caution in Use on SyreniRing 0.120 mg/0.015 mg per 24 hours, vaginal delivery system

Crescent Pharma Ltd has informed us that the Patient Information Leaflet (PIL) within the packs for the below batches is missing important safety relevant text changes.

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

The affected products' details are as follows:

PIP CodeProduct DescriptionSupplierAffected Batch

4091625SYRENIRING 0.12MG/0.015MG 24 HRCRESCENT PHARMA LTDLF18276AA
LF18894AA

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: Crescent Pharma Ltd. Medical Information Department on +00351 214643225, via email on tiago.barca@pharsolution.com or +44 (0) 1256 772740.

 

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 3 RECALL

Class 3 Recall on Digoxin Tab 250mcg

Accord-UK Ltd has informed us of an issue related to decommissioning of the above batch. 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
1063015Digoxin Tab 250mcgAccord UK LtdXDG396

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 Abstral Tab 200mcg (Schedule 2 CD)

Kyowa Kirin Limited is recalling the above batch as a precautionary measure, due to the reports of double tablets in a single blister pocket. This was identified during reference sample inspection and there is a potential low risk of accidental double dosage.

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

The affected products' details are as follows:

PIP CodeProduct DescriptionSupplierAffected Batch
3460375ABSTRAL TAB 200MCG (SCHEDULE 2 CD)KYOWA KIRIN608777302

As this product is a Schedule 2 Controlled Drug. Please ensure that these returns are sent back with the Alliance Healthcare driver, who will have a ‘Specialist Product Recall Book' with them on Thursday 30th and Friday 31st July for completion and product uplift AM ONLY. If you have recalled products to return, please have this prepared in a bag for the driver to uplift. 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. Please use our Returns Portal from Saturday 1st August for any additional returns related to this recall or alternatively call Customer Service for authorisation to return

Further Information

For Stock control enquiries please contact: Stuart Hay, Commercial Director Telephone: +44 (0) 1896 664045 Mobile: +44 (0) 7968 983286 E-mail: Stuart.Hay@kyowakirin.com For Medical information enquiries please contact:

Medical Information Direct Line: + 44 (0)1896 664 000 E-mail: medinfo@kyowakirin.com For Quality information please contact: Martin Smith (Responsible Person)

Telephone: +44 7904671807 E-mail: Martin.Smith@kyowakirin.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.

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

SUB-TYPE: CLASS 3 RECALL

Class 3 Recall on Irinotecan Vial 20mg/Ml

Accord Healthcare Limited is recalling the above batch as a precautionary measure, due to the observation of precipitation in the solution in the same batch marketed in another country (Malta). No complaints or adverse reaction reports have been received by the company to date for the UK product.

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

The affected products' details are as follows:

PIP CodeProduct DescriptionLiveryAffected Batch
1216860Irinotecan Vial 20mg/MlAccord HealthcareX21343
1123835Irinotecan Vial 20mg/MlAccord HealthcareX21343

For more information or medical information queries, please contact:Medinfo-BST Tel: 01271 385257 E-mail: medinfo@accord-healthcare.com

For stock control queries, please contact: Accord-UK Ltd Customer Services Team Tel: 0800 373573 E-mail: customerservices@accord-healthcare.com Fax: 01271 346106

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.