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Updates

SUB-TYPE: CLASS 4 CAUTION IN USE

16.12.2020

Class 4 Drug Alert (Caution in use only) Co-Careldopa 25mg/100mg tablets

 

Fairmed Healthcare GmbH has informed us of a discrepancy on the product packaging for some batches. The discrepancy relates to the incorrect spelling of one of the active pharmaceutical ingredients printed on one side of the packs in error.

 

The affected products' details are as follows:

 

PIP Code

Product Description

Supplier

Affected Batch

7089238

CO-CARELDOPA TAB 25/100MG (100)

FAIRMED HEALTHCARE GMBH

DT1912007A

DT1912006A

DT1910014B

DT1900015A

DRA07037A

DRA07036A

DRA01030A

1068535

CO-CARELDOPA TAB 25/100MG (100)

FAIRMED HEALTHCARE GMBH

 

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



For more information or medical information queries, please contact:

 

Fairmed Healthcare GmbH

Dorotheenstraße 48, 22301

Hamburg, Germany, Quality Assurance Department

or via email on QA Manager: l.rozikova@fair-med.com

 

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

SUB-TYPE: CLASS 4 CAUTION IN USE

16.12.2020

Class 4 Drug Alert (Caution in use only) Perindopril Erbumine 2mg, 4mg & 8mg Tablets

Generics [UK] Limited t/a Mylan have informed us that the Patient Information Leaflet (PIL) within the packs for the products listed above is missing relevant important safety information.

 

The affected products' details are as follows:

 

PIP Code

Product Description

Supplier

Affected Batch

Alliance do not stock

Perindopril Erbumine 2mg Tablets

Generics [UK] Limited t/a Mylan

3109619

3116084

Alliance do not stock

Perindopril Erbumine 4mg Tablets

Generics [UK] Limited t/a Mylan

3112399

8104332

Alliance do not stock

Perindopril Erbumine 8mg Tablets

Generics [UK] Limited t/a Mylan

8104319

 

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

 

For more information or medical information queries, please contact: Generics [UK] Limited t/a Mylan Medical Information Direct Line +44 (0)1707 853 000 select option 1, Customer Care direct line +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.

SUB-TYPE: CLASS 3 RECALL

CLASS 2 RECALL - SIMVADOR 10, 20 & 40mg TABLETS

Lupin Healthcare (UK) Limited has informed us that the affected batches below (also distributed by Discovery Pharmaceuticals/Dexcel Pharma Limited) have been packaged with a version of patient information leaflet (PIL) that does not include the most up to date safety information..”   

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-lupin-healthcare-uk-limited-simvador-10mg-20mg-and-40mg-tablets-el-20-a-57?utm_source=22bc7d72-98a3-44b2-b529-22cffbe3f477&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate    

Pip code

Product description

Supplier

Batch Number

2941441

SIMVADOR TABS 10MG

LUPIN HEALTHCARE

G902211

2941458

SIMVADOR TABS 20MG

LUPIN HEALTHCARE


G902283

 

2941466

SIMVADOR TABS 40MG

LUPIN HEALTHCARE

G803251

G803252

G803253

G803254

G803255

G902245

G902242

G902243

G902241

 

For stock control enquiries please contact +44 (0) 1565 751 378 Option 2 or information@lupin.com

 

For more information or medical information enquiries please contact +44 (0) 1565 751 378 Option 1 or

Pharmacovigilance Department at EU-PV@lupin.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 04/03/2021. 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 - BETAHISTINE DIHYDROCHLORIDE 8MG & 16MG TABLETS

Kent Pharmaceuticals Ltd has informed us that the affected batches above are contaminated with theophylline due to a cross-contamination issue identified with an excipient that was used in the manufacture of the finished product. Therefore, a decision has been taken to recall the affected batches

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-kent-pharmaceuticals-ltd-betahistine-dihydrochloride-8mg-and-16mg-tablets-el-20-a-55?utm_source=40c23525-b2da-4a2b-9a24-fc70e06dce17&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate

Pip code

Product description

Supplier

Batch Numbers

Alliance do not stock

Betahistine dihydrochloride 8mg Tablets

Kent Pharmaceuticals Ltd

EC10619

EC10719

EC10819

Alliance do not stock

Betahistine dihydrochloride 16mg Tablets

Kent Pharmaceuticals Ltd

GY11119

GY11219

GY11319

 

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

 

For stock control enquiries please contact customer.service@kent-athlone.com

 

For more information or medical information medical@kent-athlone.com

SUB-TYPE: CLASS 4 CAUTION IN USE

Company Led - Caution in use - Epistatus

Dear Healthcare Professional,

 

We have been made aware of Midazolam Maleate (Epistatus 10mg in 1ml Oromucosal Solution, Multidose bottle), unlicensed, emergency use medication for prolonged, acute, convulsive seizures: Potential risk of faulty and incorrectly engaged child - resistant container closure 

 

Please click here for further information 

 

Suspected drug reactions may also be reported to Veriton Pharma Ltd, Telephone +44 (0)1932 690325

 

For reporting of identified defects or queries, please contact Vertion Pharma Ltd, Telephone +44 (0) 1932690325 or email info veritonpharma.com

SUB-TYPE: CLASS 2 RECALL

CLASS 2 RECALL - LARGACTIL AMP 50MG/2ML

Sanofi is recalling the below batches due to out of specification results obtained for the impurity chlorpromazine sulphoxide, which was suspected to be caused by increased oxidation as a result of higher oxygen content in the headspace of the ampoules. As a precautionary measure, the above batches are being recalled.

Pip code

Product description

Supplier

Batch Numbers

Recall Pip code

0154914

LARGACTIL AMP 50MG/2ML

SANOFI

A90142

A90143

N/A

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

SUB-TYPE: CLASS 2 RECALL

CLASS 2 RECALL - ABSTRAL TAB 200MCG (SCHEDULE 2 CD)

Kyowa Kirin Limited is recalling the below batches as a precautionary measure, due to the reports of double tablets in a single blister pocket. This is a follow up alert, following the issue of EL (20)A/34. Since this notification, Kyowa Kirin Limited have initiated corrective actions to resolve the issue. Complaint batches 608973601 and 608973602 were manufactured prior to the corrective actions being implemented...

PIP Code

Product Description

Supplier

Affected Batch

3460367

ABSTRAL TAB 200MCG 

KYOWA KIRIN        

608973601

3460375

ABSTRAL TAB 200MCG 

KYOWA KIRIN        

608973602

 

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 Thursday 26th November and Friday 27th November  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 28th November and are unable to use the Returns Portal please call Customer Services for authorisation to return.

Further Information

For Stock control enquiries please contact: Karen Murray, Commercial Manager

Telephone: +44 (0) 7712 001288

E-mail: karen.murray@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

 

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 25/02/2021. 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 - ANCOTIL 2.5 G/250 ML SOLUTION FOR INFUSION

: Mylan UK Healthcare Ltd has been informed of a non-compliance event which occurred during the most recent inspection at the contract manufacturing site for the above product in relation to product sterility. As a precautionary measure, remaining stock of the above batches are being recalled.

PIP Code

Product Description

Supplier

Affected Batch

2116432

ANCOTIL INF

MYLAN UK HEALTHCARE

113987

114626

114711

115051

F20CBJ

                                                               

For more information or medical information enquiries please contact Mylan UK Healthcare Ltd Medical Information Department on +44(0) 1707 853000 or via email at Info.uk@mylan.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 12/02/2021. 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 - Sodiofolin 50mg/ml Solution for Injection 100mg/2ml

medac Pharma LLP is recalling the below batch of products due to some inspected vials showing hairline damage to the shoulder of the vials. So far, the company has not received any reports of damage for marketed products. However, as this defect may impact on the sterility of the product, the above batch is being recalled as a precautionary measure

PIP Code

Product Description

Supplier

Affected Batch

Alliance do not stock

Sodiofolin 50mg/ml Solution for Injection 100mg/2ml

Medac Pharma LLP

B190132C

                                                               

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

 

For more information or medical information queries, please contact info@medacpharma.co.uk or telephone 01786 458086

 

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 4 CAUTION IN USE

Class 4 Drug Caution in use - Kolanticon Gel

Intrapharm Laboratories Ltd has informed us that there is a difference in dosage instructions between the carton and label. The Patient Information Leaflet (PIL) and bottle label contain the correct instructions.

PIP Code

Product Description

Supplier

Affected Batch

0077362

KOLANTICON GEL

INTRAPHARM LABORATORIES

AA0620

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: medinfo@intrapharmlabs.com or telephone +44 (0)330 1359 437.

 

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