Class 3 recall-Atomoxetine 10mg, 18mg, 25mg, 40mg Capsules

Neuraxpharm UK Ltd is recalling specific batches after retesting showed out of specification results. The tabled batches are being recalled as a precautionary measure after testing showed variability of the capsule contents beyond permitted levels.

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-neuraxpharm-uk-ltd-atomoxetine-10mg-18mg-25mg-40mg-capsules-el-24-a-slash-19

Further Information

For medical information enquiries please contact medinfo-uk@neuraxpharm.com or telephone +44 (0) 118 211 4039

For stock control enquiries please contact info-uk@neuraxpharm.com  or telephone +44 (0) 118 211 4039

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-Lamotrigine Desitin oral suspension

Desitin Pharma UK Ltd is recalling all batches of Lamotrigine Desitin 10mg/ml Oral Suspension as a precautionary measure due to an out of specification observation in the appearance of samples during routine stability testing. Please note this is a Class 2 Patient, Pharmacy and Wholesaler level recall.

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-desitin-pharma-uk-ltd-lamotrigine-desitin-10mg-slash-ml-oral-suspension-el-24-a-slash-20?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=9f3210f7-f22d-4437-be34-72c69edae87e&utm_content=immediately

Further Information

For medical information enquiries please contact medinfo@desitin.co.uk. For stock control enquiries please contact alison.wilton@desitin.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, cannot be reimbursed by way of a credit.

Class 4 caution in use-Betamethasone Ointment 0.1% 30g

Manx Healthcare Ltd. has informed MHRA that they have identified a problem with the product packaging of the batch indicated

MHRA Drug alert date: 3rd June 2024

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-manx-healthcare-ltd-dot-betamethasone-valerate-0-dot-1-percent-ointment-el-24-a-slash-18?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=f6354607-981b-4e64-96f4-50ae75da2efb&utm_content=immediately

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

Further Information

For medical information enquiries please contact medinfo@manxhealthcare.com, or telephone: +44 (0)1926 482511.

For stock control enquiries please contact customerservice@manxhealthcare.com, or telephone: +44 (0)1926 482511.

Class 4 caution in use-Freeflex Sodium chloride 0.9%

Fresenius Kabi Limited have informed the MHRA of a packaging error with specific batches of Sodium Chloride Intravenous Infusion 0.9% Freeflex and Freeflex PLUS.

MHRA drug alert date: 22nd May 2024

MHRA Drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-fresenius-kabi-limited-sodium-chloride-0-dot-percent-intravenous-infusion-bp-freeflex-and-freeflex-plus-el-24-a-slash-17

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

Further Information

For more information or medical information queries please email Medical.Information-UK@fresenius-kabi.com or telephone +44 (0) 1928 533575.

For stock control enquiries please contact FK.complaints-uk@fresenius-kabi.com or telephone +44 (0) 1928 533758.

UPDATE: Class 3 recall-PI Keppra tablets 500mg

The class 4 caution in use on the below has now progressed to a Class 3 recall

Doncaster Pharma Limited have identified an error relating to the Braille printed on the cartons on various parallel imported packs which have been repackaged by BModesto B.V.

MHRA drug alert date: 15th May 2024

MHRA Drug alert link:  https://www.gov.uk/drug-device-alerts/class-3-medicines-defect-information-doncaster-pharma-limited-keppra-500mg-film-coated-tablets-el-24-a-slash-15?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=f0fe931b-3d3e-4a6b-b1e7-e0cfec019c27&utm_content=immediately

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.

Further Information

For medical information and stock control enquiries please contact Doncaster Pharma on tel. 01302 365 000, email quality.enquiries@doncasterpharma.co.uk or commercial@doncasterpharma.co.uk

Class 4 Caution in use-Trazodone 50mg/ml oral solution

Cygnus Pharma Ltd. Have informed MHRA that the European Article Number (EAN) barcode printed on various packs of Trazodone Hydrochloride 50mg/5ml Oral Solution, is defective and returns the incorrect information

MHRA drug alert date: 22nd May 2024

MHRA Drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-cygnus-pharma-ltd-trazodone-hydrochloride-50mg-slash-5ml-oral-solution-el-24-a-slash-16

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

Further Information

For medical information enquiries please email info@cygnuspharma.co.uk or telephone 01582 809833.

For stock control enquiries please email info@cygnuspharma.co.uk or telephone 01582 809833.

Class 4 caution in use-PI Keppra tablets 500mg

Doncaster Pharma Limited have identified an error relating to the Braille printed on the cartons on various parallel imported packs which have been repackaged by BModesto B.V.

MHRA drug alert date: 15th May 2024

MHRA Drug alert link:  https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-doncaster-pharma-limited-keppra-500mg-film-coated-tablets-el-24-a-slash-15?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=db11fb3d-2987-42ea-8b51-47915e1572c3&utm_content=immediately

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

Further Information

For medical information and stock control enquiries please contact Doncaster Pharma on tel. 01302 365 000, email quality.enquiries@doncasterpharma.co.uk or commercial@doncasterpharma.co.uk

Class 3 recall-Suprefact 1 mg/ml solution for injection

Neon Healthcare Ltd is recalling the specific batch mentioned in this notification as a precautionary measure. This is because the named batch of Suprefact 1mg/ml solution for injection is being distributed in packaging intended for the Canadian market by Cheplapharm, instead of the correct UK packaging by Neon Healthcare Ltd for Buserelin 1 mg/ml solution for injection.

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-neon-healthcare-ltd-suprefact-1-mg-slash-ml-solution-for-injection-cheplapharm-canadian-livery-el-24-a-slash-14?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=4f978699-0d51-4e8b-8090-3b47f8abd279&utm_content=immediately

Further Information

For medical information or stock control enquiries please contact: Neon Healthcare Ltd via Medinfo@neonhealthcare.com or +44 (0) 1992 926 330

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 3 recall- Co-Codamol 8/500mg effervescent tablets (Key pharmaceuticals livery

Accord-UK Ltd is recalling a specific batch of Co-Codamol 8/500mg Effervescent Tablets (Key Pharmaceuticals Livery) as a precautionary measure due to the internal tablet blister strips being printed with an incorrect expiry date.

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-accord-uk-ltd-co-codamol-8-slash-500mg-effervescent-tablets-key-pharmaceuticals-livery-el-24-a-slash-12?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=5bbfbb93-89fc-44d3-8872-098e5dc41b46&utm_content=immediately

Further Information

For medical information enquiries please contact Accord-UK Ltd’s Medical Information Department on 01271 385257, or email medinfo@accord-healthcare.com

For stock control enquiries please contact Accord-UK Ltd’s Customer Services Team on 0800 373573, or email customerservices@accord-healthcare.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 3 recall- OPDIVO 10 mg/mL concentrate for solution

Bristol-Myers Squibb Pharmaceuticals Limited has informed the MHRA that a potential product quality issue has been detected, relating to incomplete crimping of the metal crimp cap of OPDIVO 10mg/mL concentrate for solution for infusion (nivolumab) (1VLX10ML)

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-bristol-myers-squibb-pharmaceuticals-limited-opdivo-10-mg-slash-ml-concentrate-for-solution-for-infusion-nivolumab-el-24-a-slash-11

Further information

For medical information enquiries please contact the Bristol Myers Squibb Medical Information Department by phone (0800 731 1736) or email medical.information@bms.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.