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Updates

SUB-TYPE: CLASS 2 RECALL

Class 2 Recall on Mitomycin-C Kyowa, powder for solution for injection Kyowa Kirin Limited

Kyowa Kirin Ltd is recalling all unexpired batches of the products as a precautionary measure due to deviations from the aseptic manufacturing processes during the manufacture of the sterile active pharmaceutical ingredient and excipients.

 

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 STOCKMITOMYCIN-C KYOWA, 2 MG, POWDER FOR SOLUTION FOR INJECTIONKYOWA KIRIN LIMITEDALL STOCK
ALLIANCE DO NOT STOCKMITOMYCIN-C KYOWA, 10 MG, POWDER FOR SOLUTION FOR INJECTIONKYOWA KIRIN LIMITEDALL STOCK
ALLIANCE DO NOT STOCKMITOMYCIN-C KYOWA, 20 MG, POWDER FOR SOLUTION FOR INJECTIONKYOWA KIRIN LIMITEDALL STOCK
ALLIANCE DO NOT STOCKMITOMYCIN-C KYOWA 40 MG, POWDER FOR INTRAVESICAL SOLUTIONKYOWA KIRIN LIMITEDALL STOCK

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

For Stock enquiries please contact:

Stuart Hay, Commercial Director

Telephone: +44 (0) 1896 664045

Mobile: +44 (0) 7968 983286

E-mail: Stuart.Hay@kyowakirin.com

Iain Crolla, Commercial Manager

Telephone: +44 (0) 1896 661661

Mobile: +44 (0) 777 6748868

E-mail: Iain.Crolla@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:

Hazel Kennett (Responsible Person) on telephone number

Telephone: +44 (0) 1896 664025

Mobile: +44 (0) 7989 991831

E-mail: Hazel.Kennett@kyowakirin.com      

Martin Smith (Responsible Person)

Telephone: +44 (0)1896 664030

Mobile: +44 (0)7904 671 807

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.

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

SUB-TYPE: CLASS 2 RECALL

Class 2 Recall on Nutriflex Omega Plus, Nutriflex Omega Special & Unlicensed supplemented products

B Braun is initiating a recall of certain batches of the below products as a precautionary measure. This is because ongoing product monitoring has identified that some bags may not comply with the required specification throughout the product shelf-life.

 

Please visit the: MHRA Website .

 

The affected products' details are as follows:

PIP CodeProduct DescriptionSupplierAffected Batches
ALLIANCE DO NOT STOCKNUTRIFLEX OMEGA PLUSB. BRAUN MEDICAL LTDPLEASE REFER TO THE MHRA LINK ABOVE
ALLIANCE DO NOT STOCKNUTRIFLEX OMEGA SPECIALB. BRAUN MEDICAL LTDPLEASE REFER TO THE MHRA LINK ABOVE
ALLIANCE DO NOT STOCKUNLICENSED SUPPLEMENTED PRODUCTS MANUFACTURED FROM NUTRIFLEX OMEGA PRODUCTSB. BRAUN MEDICAL LTDPLEASE REFER TO THE MHRA LINK ABOVE

Alliance Healthcare do not stock. 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.

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

SUB-TYPE: CLASS 2 RECALL

Class 2 Recall on Ranitidine Soln Sf 150mg/10ml

Rosemont Pharmaceuticals Limited is recalling all unexpired stock of the above products from pharmacies as a precautionary measure due to possible contamination with an impurity N-nitrosodimethylamine (NDMA) which has genotoxic and carcinogenic potential.

 

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

 

The affected products' details are as follows:

PIP CodeProduct DescriptionLIveryAffected Batch
6288963RANITIDINE SOLN SF 150MG/10MLROSEMONT PHARMAALL STOCK
1149277RANITIDINE SOLN SF 150MG/10MLROSEMONT PHARMAALL STOCK
1151570RANITIDINE SOLN SF 150MG/10MLROSEMONT PHARMAALL STOCK
1133701RANITIDINE SOLN SF 150MG/10MLROSEMONT PHARMAALL STOCK

For stock control enquiries please contact Perrigo Customer Service team on +44 (0)1226 704711 or customerservice@perrigouk.com

For medical information enquiries please contact Perrigo Pharmacovigilance Department on +44 (0)203 598 9603 or UKLOCustomerService@perrigo.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 4 CAUTION IN USE

Class 4 Caution in Use on Rifadin (Rifampicin) 150mg Capsules

Aventis Pharma Limited t/a Sanofi has informed the MHRA that a change to the Patient Information Leaflet concerning possible side effects for Rifadin (rifampicin) 150mg Capsules has not been implemented by the required timeline.

 

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

 

The affected products' details are as follows:

PIP CodeProduct DescriptionSupplierAffected Batch
240838RIFADIN CAP 150MGSANOFI9G020A

For medical information enquiries, please contact Sanofi Medical Information, Tel +44 (0) 845 372 7101; email uk-medicalinformation@sanofi.com.
 

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

 

Please note that this is a caution in use only and we are not accepting stock returns.

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

SUB-TYPE: COMPANY-LED RECALL

Company-Led Recall on DOCETAXEL VIAL 80MG/8ML

Pfizer UK Limited is recalling the below batches. This is because routine stability testing has identified that levels of a known impurity, 10-oxo-docetaxel, may exceed the acceptable level at end of shelf-life.

 

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

 

The affected products' details are as follows:

PIP CodeProduct DescriptionSupplierAffected Batch
8120883DOCETAXEL VIAL 80MG/8MLPFIZER LTDS0130118
S0140518

Please do not consolidate any stock for return. All returns must be from the original delivery address. Any product(s) returned from non-Pfizer accounts will be retained by the distribution centre and not returned. Credit for these returned products must be obtained from the supplier from where the product was purchased.

All Stock must be returned to Alliance Healthcare before the 14th January 2020.

For medical information please contact Pfizer Medical Information Department on 01304 616161

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 Bisacodyl Supps 10MG

Martindale Pharmaceuticals Limited is recalling all remaining stock of the below batche due to an issue with homogeneity. This may result in individual suppositories containing too little or too much active substance.

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

The affected products' details are as follows:

PIP CodeProduct DescriptionSupplierAffected Batch
7013899BISACODYL SUPPS 10MGMARTINDALE PHARMACEUTICALS LTDBUK901

For stock control enquiries please contact Martindale Pharmaceuticals Limited email: licensed@ethypharm.com.

For medical information enquiries please contact Martindale Pharmaceuticals Limited email on email: medinfo@ethypharm.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 - Field Safety Notice on Super Absorbent Dressing

Richardson Healthcare has released a field safety notice for the below batches of Super Absorbent Dressing after carrying out a stock check of the Sterile Super Absorbent Dressing and found the afore mentioned six batch numbers of the Sterile Super Absorbent Dressing are missing the paper IFU insert in their inner boxes.

This is a Caution in Use Class 3 Recall - Field Safetly Notice Only.

The affected products' details are as follows:

PIP CodeProduct DescriptionSupplierAffected Batch
3925351Super Absorbent dressing, 7.5 x 7.5 cmRichardson Healthcare190328
3925369Super Absorbent dressing, 10 x 10 cmRichardson Healthcare190408
3925377Super Absorbent dressing, 10 x 20 cmRichardson Healthcare190329
3925401Super Absorbent dressing, 15 x 25 cmRichardson Healthcare190330
3925385Super Absorbent dressing, 20 x 20 cmRichardson Healthcare190407
3925393Super Absorbent dressing, 20 x 30 cmRichardson Healthcare190331

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

 

This is an NWOS only recall and 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: FMD ALERT

FMD Alert: Class 2 Recall on Kosei Pharma, Mpt Pharma, Doncaster Pharma, Drugsrus Ltd/P.I.E Phara PI

Kosei Pharma UK Ltd, MPT Pharma Ltd, Doncaster Pharmaceuticals Group Ltd & Drugsrus Ltd / P.I.E. Pharma Ltd are recalling various parallel imported products (PI) as it has come to our attention that these medicines have been taken out of the regulated medicines' supply chain during distribution and later re-introduced. This means that the correct transport and storage conditions cannot be guaranteed during this period and, whilst unlikely, could impact their effectiveness. The products are believed to be legitimate. There is no evidence that they have been tampered with and these medicines are stable at room temperature. Following the issue of FMD Alert EL (19)A/15 on 27 June 2019, we have become aware that Kosei Pharma UK Ltd, CST Pharma Ltd and Ordinant Medical Solutions Ltd have also parallel imported some affected products into the UK from Italy and they have been re-labelled in Kosei Pharma UK Ltd, MPT Pharma Ltd, Drugsrus Ltd / P.I.E. Pharma Ltd and Doncaster Pharmaceuticals Group Ltd livery.

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

The affected products' details are as follows:

Recall Details
Please refer to the MHRA link above for product details and affected batch details.

Only Kosei Pharma UK Ltd, MPT Pharma Ltd, Doncaster Pharmaceuticals Group Ltd & Drugsrus Ltd / P.I.E. Pharma Ltd liveries are within the scope of this Alert.

For Kosei Pharma UK Ltd general enquiries please contact Mr. Saket Jadhav Tel: 01753515054: Email: saket.j@koseipharma.com

For Kosei Pharma UK Ltd medical information enquiries please contact Mr. Kalpesh Patel Tel: 01753515050: Email: Kalpeshkumar.p@koseipharma.com

For MPT Pharma Ltd all enquiries please email productrecalls@mptpharma.co.uk

For Doncaster Pharmaceuticals Group Ltd all enquiries please email Rachael Hill, Email: rachael.hill@doncaster-pharm.com Tel 01302 554804 or Richard Gore, Email: richard.gore@doncaster-pharm.com Tel: 01302 554805

For Drugsrus Ltd / P.I.E. Pharma Ltd all enquiries please contact Drugsrus Customer Services, Email: recall@drugsrus.co.uk Tel: 020 8423 3800
 

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 Bisacodyl Tab 5mg X 1000

Chanelle Medical is recalling the below batch because a small number of packs have been found to contain tablets which are stuck together, with mould observed on some tablets. The mould has been identified as a Penicillium species. It is unlikely that affected tablets will have got to patient level as the sticking is noticeable on opening the pack..

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

The affected products' details are as follows:

PIP CodeProduct DescriptionSupplierAffected Batch
8096331BISACODYL TAB 5MG X 1000CHANELLE MEDICAL25074A

For stock enquiries please contact David Hammond, General Manager, Healthcare Pharma: Tel: 01233 822 297 Email: rp@healthcarepharma.co.uk.

For medical information enquiries please contact Anne Dougherty, Operations Director, Panacea Pharma Projects, Isle of Man: Tel: 44-1624 672777 Email: anne.dougherty@panacea.im.

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 Emerade 150, 300, 500 Micrograms Pfs

Bausch & Lomb UK limited has informed us of a risk of Emerade product failing to deliver a dose of adrenaline from the syringe due to blockage of the needle.

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

The affected products' details are as follows:

PIP CodeProduct DescriptionSupplierAffected Batch
3849221EMERADE 150 AUTO-INJECTORBAUSCH & LOMB UKALL STOCK
3849239EMERADE 300 AUTO-INJECTORBAUSCH & LOMB UKALL STOCK
3849247EMERADE 500 AUTO-INJECTORBAUSCH & LOMB UKALL STOCK

Please note that Alliance Healthcare do not stock and as this is a caution in use only we are not accepting stock returns.

For stock enquiries please contact Bausch & Lomb Customer Services: Tel: 0208 781 2991 Email: Pharma_CS@bausch.com.

For medical information enquiries please contact Lizanne Kombrink, Pharmacovigilance and Medical Information Officer: Tel: 0208 781 5523 Email: Pharmacovigilance.UK@bausch.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.