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Ticker Update

Updates

SUB-TYPE: CLASS 2 RECALL

Class 2 Recall - Water for Injections BP – 100ml vial x 25

Hameln pharma ltd are recalling batches of product additional to the batch recalled on 15 February 2022 (reference EL(22)A/06). This recall is conducted as a precautionary measure, as remaining vials may no longer be in line with the licensed product specification with respect to the parameters pH and conductivity.

 

MHRA drug alert date: 25 May 2022

 

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-hameln-pharma-ltd-water-for-injections-bp-100ml-vial-el-22-a-slash-24?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=5178b109-19c7-4882-b7e7-ee9285e62098&utm_content=immediately

 

Pip code

Product description

Supplier

Batch Numbers

0769489

WATER FOR INJ BP VIAL R/C 100ML (25)

HAMELN PHARMACEUTICALS LTD (MOV)

019501

019502

019503

019504

019505

019506

920503

920506

920508

930503

930504

930505

931501

940501

940502

951504

952501

Further Information

 

For more information, medical or supply enquiries, please contact: drug.safety@hameln-pharma.co.uk

 

For stock control queries, please contact: customer.services@hameln-pharma.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.

 

Please note that anything not returned to us, or notified to us, within 3 months of this notification by the 26 August 2022, cannot be reimbursed by way of a credit

SUB-TYPE: CLASS 2 RECALL

Class 2 Recall - Mefenamic Acid 500mg film coated, 30 tablets

Quadrant Pharmaceuticals Ltd are recalling a specific batch of Mefenamic Acid 500mg Film-Coated, 30 Tablets as a precautionary measure, due to observations of a defective layer of film coating in some tablets, resulting in the tablet core being partially exposed.

 

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-quadrant-pharmaceuticals-ltd-mefenamic-acid-500mg-film-coated-tablets-el-22-a-slash-23?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=bc363bcf-f3dc-4fbf-9017-327ecb34cd6f&utm_content=immediately

 

Pip code

Product Description

Supplier

Batch Numbers

ALLIANCE DO NOT STOCK

MEFENAMIC ACID 500MG FILM COATED, 30 TABLETS

QUADRANT PHARMACEUTICALS LTD

107082

Alliance do not stock the above product so we will not be accepting Customer returns on this recall.

 

Further Information

 

For more information, medical or supply enquiries, please contact joanne.fishwick@maxearn.co.uk or radoslaw.bandomir@maxearn.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.

SUB-TYPE: CLASS 4 CAUTION IN USE

Class 4 Drug Caution In Use - Zovirax I.V. 500mg

GlaxoSmithKline UK Ltd have informed the MHRA that an incorrect version of the Summary of Product Characteristics section 4.2 and the Patient Information Leaflet is inside the sealed pack, and contains unapproved text.

 

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-glaxosmithkline-uk-ltd-zovirax-iv-500-mg-el-22-a-slash-22?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=2fba3ba7-af6b-48f5-bcb3-903db16db3f2&utm_content=immediately

 

Pip code

Product description

Supplier

Batch Numbers

489633

ZOVIRAX IV VIAL 500MG

GLAXOSMITHKLINE UK LTD

9G4B

TC8E-A

6V8W

GN8S

J69C

B35J

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

 

Further Information

If you have any questions, please contact GSK UK Ltd Medical Information Department on 0800 221 441 or email: ukmedinfo@gsk.com

SUB-TYPE: CLASS 2 RECALL

Class 2 Recall - Accupro 5mg, 10mg, 20mg, 40mg film-coated tablets

Pfizer Limited are recalling all batches of Accupro 5mg, 10mg, 20mg, 40mg film-coated tablets as a precautionary measure.

 

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-pfizer-limited-accupro-5mg-10mg-20mg-40mg-film-coated-tablets-el-22-a-slash-21?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=c46b413b-c065-46f9-8947-94cdaeced6c0&utm_content=immediately

 

Pip code

Product description

Supplier

Batch Numbers

258764

ACCUPRO TAB 5MG X 28

PFIZER LTD

FJ7218

EY5501

EA9306

258780

ACCUPRO TAB 10MG X 28

PFIZER LTD

FK8588

EP6753

258822

ACCUPRO TAB 20MG X 28

PFIZER LTD

FF8046

FF8045

EA9304

DK4190

2035467

ACCUPRO TAB 40MG X 28

PFIZER LTD

FK9758

EP1602

CW7390

Further Information

 

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

 

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.

 

Please note that anything not returned to us, or notified to us, within 3 months of this notification, cannot be reimbursed by way of a credit.

SUB-TYPE: CLASS 2 RECALL

Class 2 Recall - Sodium bicarbonate 1.26% Solution for infusion 500ml

Fresenius Kabi Limited are recalling the below batch of product as a precautionary measure due to the identification of particles in the solution for infusion, following routine batch analysis and subsequent batches manufactured on the same filling line. The company’s investigation indicates that he particles appear to originate from the interaction between the equipment and the packaging material during the filling process. The integrity of the packaging and sterility of the product are not compromised.

 

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-fresenius-kabi-limited-sodium-bicarbonate-1-dot-26-percent-solution-for-infusion-el-22-a-slash-20?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=ca886a23-3a40-4c69-811e-b116b6a59264&utm_content=immediately

 

Pip code

Product description

Supplier

Batch Number

ALLIANCE DO NOT STOCK

SODIUM BICARBONATE 1.26% SOLUTION FOR INFUSION 500ML

FRESENIUS KABI LIMITED

22BC01

Further Information

 

For more information, medical or supply enquiries, please contact 01928 533 758 FK.Complaints-UK@fresenius-Kabi.com or Customer.Services-UK@Fresenius-Kabi.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.

SUB-TYPE: CLASS 2 RECALL

Class 2 Recall - Paroxetine 40mg Film Coated X 30 Tablets

Crescent Pharma Limited are recalling the below batch of product as a precautionary measure due to out of specification results for dissolution during routine stability testing.

 

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-crescent-pharma-limited-paroxetine-40mg-film-coated-tablets-el-22-a-slash-19?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=768b741e-cf2d-41d0-8fa1-811dd1fb6f43&utm_content=immediately

 

Pip code

Product description

Supplier

Batch Numbers

8150096

PAROXETINE TAB 40MG X 30

CRESCENT PHARMA LTD

06309

Further Information

 

For more information, medical or supply enquiries, please contact 01256 772730  

 

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.

 

Please note that anything not returned to us, or notified to us, within 3 months of this notification, cannot be reimbursed by way of a credit.

SUB-TYPE: CLASS 4 CAUTION IN USE

Class 4 Drug Caution In Use - Depo-Medrone with Lidocaine 40 mg/mL (1 mL and 2 mL vials – single vial preparations)

Pfizer Limited have informed the MHRA that an outdated version of the Patient Information Leaflet (PIL) has been included in the packaging of the above mentioned batches of Depo-Medrone with Lidocaine (Methylprednisolone acetate and Lidocaine hydrochloride) 40 mg/mL 1 mL and 2 mL vials (single vial presentations) to the UK market.

 

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-pfizer-limited-depo-medrone-with-lidocaine-40-mg-slash-ml-1-ml-and-2-ml-vials-single-vial-preparations-el-22-a-slash-18?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=9485c83a-e291-4936-818f-71376a60455f&utm_content=immediately

 

Pip code

Product description

Supplier

Batch Numbers

2343036

DEPO MEDRONE LIDOCAIN 40MG/ML, 1ML

PFIZER LTD

EL4771

FK6842

294892

DEPO MEDRONE LIDOCAIN 40MG/ML, 2ML

PFIZER LTD

EK3997

FK6089

FN9557

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

 

Further Information
If you have any questions, please contact Pfizer Medical Information Department on 01304 616161

SUB-TYPE: CLASS 2 RECALL

Class 2 Recall - Olopatadine USV 1mg/mL eye drops 5ml

USV UK Limited are recalling specific batches of products as a precautionary measure due to out of specification results for impurities during routine stability testing.

 

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-usv-uk-limited-olopatadine-usv-1mg-slash-ml-eye-drops-solution-el-22-a-slash-17?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=fdc295a6-ab88-476f-954b-60c595629a00&utm_content=immediately

 

Pip code

Product description

Livery

Batch Numbers

8943771

OLOPATADINE USV 1MG-ML EYE DROPS 5ML

USV UK LIMITED

35000201

35000202

35000203

35000204

35000206

Further Information

 

For more information, medical or supply enquiries, please contact info@ennogen.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.

 

Please note that anything not returned to us, or notified to us, within 3 months of this notification, cannot be reimbursed by way of a credit.

SUB-TYPE: CLASS 2 RECALL

Class 2 Recall - Accuretic 10/12.5 mg film-coated tablets

Pfizer Ltd are recalling batch number DD4842 as a precautionary measure due to the identification of a nitrosamine above the acceptable limit.

 

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-pfizer-limited-accuretic-10-slash-12-dot-5-mg-film-coated-tablets-el-22-a-slash-16?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=aa52a52c-2b0d-4e40-bcc1-82255ece8cd4&utm_content=immediately

 

Pip code

Product description

Supplier

Batch Number

64733

ACCURETIC TABLETS 10/12.5 X 28

PFIZER LTD

DD4842

Further Information

 

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

 

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.

 

Please note that anything not returned to us, or notified to us, within 3 months of this notification, cannot be reimbursed by way of a credit.

SUB-TYPE: CLASS 4 CAUTION IN USE

Class 4 Drug Caution In Use - Benzylpenicillin benzathine 1.2 Million I.U. and 2.4 Million I.U. powder and solvent for suspension for injection

Brancaster Pharma Limited have notified us of an issue relating to the label of the Water for Injections (solvent) packaged in each finished product pack.

 

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-benzylpenicillin-benzathine-1-dot-2-million-iu-and-2-dot-4-million-iu-powder-and-solvent-for-suspension-for-injection-el-22-a-slash-15?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=0932503e-1ef9-44ca-ae54-31760eaacaf9&utm_content=immediately

 

Pip code

Product description

Supplier

Batch Numbers

1237783

BENZATHINE (BENZYLPEN) 1.2MILL IU

BRANCASTER PHARMA LTD

72C00215

72C00116

72N00206

1237791

BENZATHINE (BENZYLPEN) 2.4MILL IU

BRANCASTER PHARMA LTD

72C00216

72C00220

72C00223

72N00207

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

 

Further Information

For medical information and stock control queries please contact: safety@brancasterpharma.com