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Updates

SUB-TYPE: CLASS 2 RECALL

Class 2 Recall on Levothyroxine 100micrograms/5ml Oral Sol Wockhardt UK Ltd

Wockhardt UK Ltd is recalling specific batches of Levothyroxine 100micrograms/5ml Oral Solution from pharmacies and wholesalers as a precautionary measure due to notification of the impurity liothyronine exceeding the specification limit.

 

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

 

The affected products' details are as follows:

PIP CodeProduct DescriptionSupplierAffected Batch
1181338LEVOTHYROXINE SOL 100MCG/5MLWOCKHARDT UK LTDI53481
I54522
6329643LEVOTHYROXINE SOL SF 100MCG/5MLWOCKHARDT UK LTDI53481
I54522
1152115LEVOTHYROXINE SF 100MCG/5MLWOCKHARDT UK LTDI53481
I54522

For medical Information enquiries, please contact Medical Information on 01978 661261 or email drug.safety@wockhardt.co.uk.

For enquiries relating to stock returns please contact Wockhardt UK Ltd Customer Services on 01978 661261 or email customer.services@wockhardt.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 4 CAUTION IN USE

Class 4 Caution in Use on Finasteride tablets 5mg Dr Reddy's

Dr. Reddy's Laboratories (UK) Ltd has informed us that the Patient Information Leaflet (PIL) for the above batches is missing the special warning and precautions.

 

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

 

The affected products' details are as follows:

PIP CodeProduct DescriptionLiveryAffected Batch
1147859FINASTERIDE TAB 5MGDR. REDDY'S LABORATORIESPlease refer to MHRA Link
1135516FINASTERIDE TAB 5MGDR. REDDY'S LABORATORIESPlease refer to MHRA Link
1178482FINASTERIDE TAB 5MGDR. REDDY'S LABORATORIESPlease refer to MHRA Link
1133719FINASTERIDE TAB 5MGDR. REDDY'S LABORATORIESPlease refer to MHRA Link
1139989FINASTERIDE TAB 5MGDR. REDDY'S LABORATORIESPlease refer to MHRA Link

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

 

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

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

SUB-TYPE: CLASS 2 RECALL

Class 2 Recall on Picato 150 Mcg/G Gel / Picato 500 Mcg/G Gel Leo Pharma

LEO Laboratories Ltd (T/A LEO Pharma) is recalling all unexpired stock of the above products from pharmacies and wholesalers as a precautionary measure due to concerns on the possible risk of skin malignancy.

 

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

 

The affected products' details are as follows:

PIP CodeProduct DescriptionSupplierAffected Batch
3765732PICATO GEL 150MCG/GLEO PHARMA LTDALL STOCK
3765757PICATO GEL 500MCG/GLEO PHARMA LTDALL STOCK
6839252PICATO GEL 150MCG/GOTC DIRECT (PI'S)ALL STOCK
8430241PICATO GEL 500MCG/GOTC DIRECT (PI'S)ALL STOCK

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

 

For medical information enquiries please contact LEO Pharma Medical Information Department on 01844 347 333 and press 2 for Medical Information, or by email at medical-info.uk@leo-pharma.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.

 

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 Zapain Tablets 30/500mg

Advanz Pharma has informed us of a discrepancy on the product packaging for the batches listed within this alert. The discrepancy relates to "capsules" printed at the top right of the packs in error (where this should be tablets). The other product details on the packs including the name, strength and pharmaceutical form of the medicine are correct.

 

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

 

The affected products' details are as follows:

PIP CodeProduct DescriptionSupplierAffected Batch
2734705ZAPAIN TABLETS 30/500MGAdvanz PharmaPLEASE REFER TO THE MHRA LINK ABOVE

For stock control queries please contact on 08708 877025 or customercare@advanzpharma.com.

For any medical information enquires please contact Medical Information Department on the e-mail medicalinformation@advanzpharma.com or telephone on 08700 703033.

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

 

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: COMPANY-LED RECALL

Company-Led Recall on PACLITAXEL VIAL 150MG Pfizer

Hospira UK Limited (Pfizer) is recalling the above batch of the Paclitaxel 6 mg/ml concentrate for solution for infusion (150mg/25ml) as a precautionary measure. This is due to a manufacturing issue which could potentially have resulted in a loss of sterility assurance.

 

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

 

The affected products' details are as follows:

PIP CodeProduct DescriptionSupplierAffected Batch
8121204PACLITAXEL VIAL 150MGPFIZER LTDF016842AD

For stock enquiries, please contact your original supplier or local branch of Alliance Healthcare.

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.

Stock should not be consolidated and returns should be sent back to your original supplier. 

The final date for accepting stock back for credit is 18 March 2020. 

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 Emerade Auto-Injectors Bausch & Lomb UK

Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) is recalling all unexpired batches of the above product due to an error in one component of the autoinjector believed to cause some pens to fail to activate and deliver adrenaline.

 

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 the 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.

 

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 75mg Tabs - Various Liveries

OTC Concepts Ltd, Relconchem Ltd and Noumed Life Sciences Ltd are recalling all unexpired batches of the below products from pharmacies and retail stores as a precautionary measure due to possible contamination with an impurity N-nitrosodimethylamine (NDMA) which has genotoxic and carcinogenic potential. Medreich Plc are recalling specific batches of the above products from pharmacies and retail stores 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 .

 

The affected products' details are as follows:

PIP CodeProduct DescriptionSupplierAffected Batches
1130608ALMUS RANITIDINE TAB 75MGNOUMED LIFE SCIENCES LIMITEDALL STOCK
2978211GAVILAST H2 TABNOUMED LIFE SCIENCES LIMITEDALL STOCK
ALLIANCE DO NOT STOCKRanitidine 75mg TabletsOTC Concepts LimitedPLEASE REFER TO THE MHRA LINK ABOVE
ALLIANCE DO NOT STOCKRanitidine 75mg TabletsRelonchem LimitedPLEASE REFER TO THE MHRA LINK ABOVE
ALLIANCE DO NOT STOCKPLEASE REFER TO THE MHRA LINK ABOVEMedreich PLCPLEASE REFER TO THE MHRA LINK ABOVE

OTC Concepts Limited For stock control enquiries please contact Customer Service team on +44 (0) 1484 665733 or Warehouse@dalkeithlabs.co.uk. For medical information enquiries please contact Pharmacovigilance Department on +44 (0) 1525 292344 or RanitidinePV@dalkeithlabs.co.uk

Relonchem Limited For stock control enquiries please contact Relonchem Customer Service team on +44 (0) 151 422 1200 or sales@relonchem.com For medical information enquiries please contact Relonchem Pharmacovigilance Department on +44 (0) 151 556 1857 or medicalinformation@relonchem.com

Noumed Life Sciences Limited For stock control enquiries please contact Noumed Life Sciences Limited Customer Service team on +44 (0) 2033998900 or nicole.mascowe@noumed.co.uk For medical information enquiries please contact Noumed Life Sciences Limited Pharmacovigilance Department on Tel +44 (0) 2033998960 or akhtarhms@skayedzan.co.uk

Medreich PLC For stock control enquiries please contact Medreich Plc. Customer Service team on +44 (0) 20 8831 1580 or cs_team@medreich.co.uk For medical information enquiries please contact Medreich Plc. Pharmacovigilance Department on +44 (0) 20 8831 1580 or qagroup@medreich.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.

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

SUB-TYPE: CLASS 3 RECALL

Class 3 Recall on Folic Acid Tablets BP 5mg Accord-UK Ltd

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
1082742FOLIC ACID TAB 5MGAccord-UKHU57
1115724FOLIC ACID TAB 5MGAccord-UKHU57
1117191FOLIC ACID TAB 5MGAccord-UKHU57
1077692FOLIC ACID TAB 5MGAccord-UKHU57

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 Omeprazole 40 mg powder for solution for infusion Sandoz Limited

Sandoz Limited is recalling the above batch due to the occurrence of degradation in some vials, resulting in green discoloration of the powder in the vial, leading to increased levels of impurities/degradation products in the medicine. The manufacturer has confirmed the root cause to be an extended exposure to a UV light located within the warehouse and this only affects the batch listed above.

 

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

 

The affected products' details are as follows:

PIP CodeProduct DescriptionLiveryAffected Batch
1170133OMEPRAZOLE PDR VIAL 40MGSandoz LimitedJS1355

For enquiries relating to stock returns please contact Sandoz Limited Customer Services on 01276 698607 or email sales.sandoz-gb@sandoz.com

For medical information enquiries, please contact Sandoz Medical Information Team on 01276 698101 or email sandozgb@EU.propharmagroup.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 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.