Class 4 caution in use-Sandoz Omeprazole

Sandoz Ltd. has informed the MHRA that there is missing safety information in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPCs) of the specific products listed in this notification.

MHRA Drug alert date: 7th August 2024

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-sandoz-limited-omeprazole-products-el-24-a-slash-34?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=ea1dca7f-9fca-4f37-ae61-6f98b6648de6&utm_content=immediately

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

Further Information

For more information or medical information queries, please email sandozgb@EU.propharmagroup.com, or telephone: +44 1276 698 101

For stock control queries, please email sales.sandoz-gb@sandoz.com, or telephone: +44 1276 698607

Class 3 recall-Atomoxetine capsules (all strengths, Glenmark livery)

Glenmark Pharmaceuticals Europe Ltd is recalling various batches after retesting showed out of specification results.

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-glenmark-pharmaceuticals-europe-ltd-atomoxetine-10mg-18mg-25mg-10mg-40mg-60mg-80mg-and-100mg-hard-capsules-el-24-a-slash-33?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=339a2ad8-94c4-464c-b54b-0bf153811e35&utm_content=immediately

Further Information

For medical information enquiries please use the following options by phone +44 08004 580 383 or email medical_information@glenmarkpharma.com

For stock control enquiries please email orders.uk@glenmarkpharma.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 4 caution in use-Co-trimoxazole 80mg/400mg per 5ml adult suspension

Aspen Pharma Trading Limited has informed the MHRA that an error has been found in the Patient Information Leaflet.

MHRA Drug alert date: 25th July 2024

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-aspen-pharma-trading-limited-co-trimoxazole-80mg-slash-400mg-per-5ml-adult-suspension-el-24-a-slash-32?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=81536038-7615-41f4-b4e5-092e1062ba23&utm_content=immediately

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

Further Information

For medical information enquiries please contact: Aspenmedinfo@professionalinformation.co.uk,
Tel: 0800 008 7392

Class 4 caution in use-Freeflex/Steriflex No. 11 Hartmann's solution

Fresenius Kabi Limited has informed the MHRA of a labelling error on the packaging of Hartmann’s solution for Injection BP as Steriflex No.11 or freeflex.

MHRA Drug alert date: 24th July 2024

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-fresenius-kabi-limited-hartmanns-solution-for-injection-bp-as-steriflex-no-11-or-freeflex-el-24-a-slash-31?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=266c16df-6328-44c8-bc25-a79181e2bf0f&utm_content=immediately

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) 1928533575.

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

Class 2 recall-Flolan 1.5 mg Powder and Solvent for Solution for Infusion

Glaxo Wellcome UK Ltd (GSK) has informed the MHRA that vials of Flolan 1.5 mg Powder and Solvent for Solution for Infusion, batch number AB8M may have been damaged during the packaging process.

MHRA drug alert link:  https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-glaxo-wellcome-uk-limited-trading-as-glaxosmithkline-uk-flolan-1-dot-5-mg-powder-and-solvent-for-solution-for-infusion-el-24-a-slash-30

Further Information

Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

For more information on stock and resupply queries, contact your hospital or homecare provider. In the case of NHS trusts please contact 0800 221 441.

Should you have any questions or require additional information, please contact GSK Medical Information Department at ukmedinfo@gsk.com or alternatively contact 0800 221 441.

Class 2 recall-Pemetrexed 100mg/1100mg Infusion bag

Sun Pharmaceutical Industries Europe B.V. is recalling the listed batches as a precautionary measure due to visible particulate matter during stability testing.

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-sun-pharma-uk-limited-pemetrexed-1000mg-slash-100ml-10mg-slash-ml-and-1100mg-slash-100ml-11mg-slash-ml-infusion-bag-el-24-a-slash-29?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=072b40d3-df8c-47dd-a6b7-6c15a2e30f34&utm_content=immediately

Further Information

For medical information enquiries please contact, medinfoeurope@sunpharma.com.

For stock control enquiries please contact Sun Pharma Customer Service, Cserv.uk@sunpharma.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-Gemcitabine PPF 1800mg/180mL Infusion; Gemcitabine PPF 1600mg/160mL Infusion; Irinotecan PPF 360mg/240mL Infusion

Sun Pharma UK Ltd is recalling certain batches as a precautionary measure due to a small number of leaks found intermittently in the infusion bags.

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-sun-pharma-uk-limited-gemcitabine-ppf-1800mg-slash-180ml-infusion-gemcitabine-ppf-1600mg-slash-160ml-infusion-irinotecan-ppf-360mg-slash-240ml-infusion-el-24-a-slash-28?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=d2d18634-9729-4c08-ab73-4f5410162e11&utm_content=immediately

Further Information

For medical information enquiries please contact, medinfoeurope@sunpharma.com.

For stock control enquiries please contact Sun Pharma Customer Service, Cserv.uk@sunpharma.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 4 caution in use-Propantheline Tablets 15mg (Genesis Pharmaceuticals livery)

Chelonia Healthcare Limited has informed the MHRA that an error relating to the product description was identified in the Patient Information Leaflet (PIL) for the batches listed in this notification.

MHRA Drug alert date: 9th July 2024

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-chelonia-healthcare-limited-propantheline-tablets-15mg-genesis-pharmaceuticals-livery-el-24-a-slash-27?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=f28f044e-ba2e-41cd-8103-d934702d907b&utm_content=immediately

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

Further Information

For stock control queries please contact info@genesis-pharma.com (Tel 020 7201 0400)

For Medical queries please contact eupvg@genreg.eu (Tel: 020 7201 0421).

Class 2 recall-Itraconazole 10mg/ml Oral Solution

Kent Pharma UK is recalling various batches of Itraconazole 10mg/ml Oral Solution as a precautionary measure due to out of specification in the appearance of the solution, particularly the presence of suspended particles or clusters of crystals.

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-kent-pharma-uk-itraconazole-10mg-slash-ml-oral-solution-el-24-a-slash-26?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=f48bd582-6f15-4f98-9b73-467a2563cd4e&utm_content=immediately

Further Information

For medical information enquiries please contact medical@kent-athlone.com

For stock control enquiries please contact customer.services@kent-athlone.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-Atomoxetine capsules (all strengths, Accord livery)

Accord Healthcare Ltd is recalling various 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-accord-healthcare-ltd-atomoxetine-10mg-18mg-25mg-40mg-60mg-80mg-100mg-hard-capsules-el-24-a-slash-25?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=15af204d-8a5a-40bb-91f9-12e8776e19d9&utm_content=immediately

Further Information

For medical information enquiries please contact Accord-UK Ltd Medical Information Department on 01271 385257

For stock control enquiries please contact Accord- UK Ltd Customer Services Team on 0800 373573. 

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.