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

Company Led Recall - NETSPOT (Kit for the preparation of gallium Ga 68 dotatate injection) [unlicensed medicine]

Advanced Accelerator Applications is recalling specific batches of this product as a precautionary measure due to an out of specification result that was identified during stability testing.

MHRA drug alert link: 

https://www.gov.uk/drug-device-alerts/company-led-medicines-recall-advanced-accelerator-applications-netspot-kit-for-the-preparation-of-gallium-ga-68-dotatate-injection-unlicensed-medicine-clmr-22-a-slash-02?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=1f3d3fed-4932-4368-813d-6fcf6dd2ef00&utm_content=immediately

Alliance do not stock this product and therefore we are not accepting stock returns.

Company contact for medical enquiries

For more medical information please contact Diane Fogarty: diana.fogarty@novartis.com

Company contact for stock enquiries

For more stock information please contact Jane Farr: jane.farr@novartis.com

Class 4 Drug Caution In Use - Beclometasone dipropionate 50 micrograms/dose Nasal Spray (Various Liveries)

Ayrton Saunders Limited have identified an error relating to the Braille printed on the cartons.

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-ayrton-saunders-limited-beclometasone-dipropionate-50-micrograms-slash-dose-nasal-spray-various-liveries-el-22-a-slash-14?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=3cee273e-9974-4dab-91dc-ef9076df844b&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: Ayrton Saunders Ltd., 9 Arkwright Road, Astmoor Industrial Estate, Runcorn, Cheshire, WA7 1NU or quality@ayrtons.com

Class 4 Drug Caution In Use - Latuda film-coated tablets

CNX Therapeutics Ltd. have notified the MHRA that the batches of Latuda film-coated tablets listed in this notification will be released without EAN barcodes on the cartons.

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-cnx-therapeutics-ltd-latuda-film-coated-tablets-el-22-a-slash-13?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=dac1ea2a-e6e3-4479-b1e3-e8b6894509b8&utm_content=immediately

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

Further Information

For more information and medical information contact: medinfo@cnx-therapeutics.com

For stock control queries please contact: supplychain@cnx-therapeutics.com