Ticker Update

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

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

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

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.

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

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

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

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.

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

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.

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

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.

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

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

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

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.

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

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.

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

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