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Updates

SUB-TYPE: CLASS 2 RECALL

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

 

Pip code

Product Description

Affected Batches

1264035

PEMETREXED INF BAG 1000MG SUN

HAF0083A

1263979

PEMETREXED INF BAG 1100MG SUN

HAE0425A

 

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.

SUB-TYPE: CLASS 2 RECALL

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

 

 

Pip code

Product Description

Affected Batches

1211135

GEMCITABINE INF BAG 1800MG SUN

HAD3634A

1211119

GEMCITABINE INF BAG 1600MG SUN

HAE1532A

1244367

IRINOTECAN INF BAG 360MG SUN

HAE1191A

 

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.

SUB-TYPE: CLASS 4 CAUTION IN USE

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

 

 

Pip code

Product description

Supplier

Batch Numbers

8057119

PROPANTHELINE BROMIDE TAB 15MG

 GENESIS PHARMACEUTICALS LTD

SEE ATTACHED

 

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).

SUB-TYPE: CLASS 2 RECALL

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

 

Pip code

Product Description

Affected Batches

8073249

ITRACONAZOLE SF SOLN 10MG/ML

231069

231071

 

 

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.

SUB-TYPE: CLASS 3 RECALL

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

 

Pip code

product description

batch number

1204288

ATOMOXETINE CAP 10MG ACC (28)

SEE ABOVE LINK

1204270

ATOMOXETINE CAP 10MG ACC (7)

SEE ABOVE LINK

1204304

ATOMOXETINE CAP 18MG ACC (28)

SEE ABOVE LINK

1204296

ATOMOXETINE CAP 18MG ACC (7)

SEE ABOVE LINK

1204320

ATOMOXETINE CAP 25MG ACC (28)

SEE ABOVE LINK

1204312

ATOMOXETINE CAP 25MG ACC (7)

SEE ABOVE LINK

1204346

ATOMOXETINE CAP 40MG ACC (28)

SEE ABOVE LINK

1204338

ATOMOXETINE CAP 40MG ACC (7)

SEE ABOVE LINK

1204353

ATOMOXETINE CAP 60MG ACC

SEE ABOVE LINK

1204361

ATOMOXETINE CAP 100MG ACC

SEE ABOVE LINK

1204379

ATOMOXETINE CAP 80MG ACC

SEE ABOVE LINK

8009359

ATOMOXETINE CAP 18MG

SEE ABOVE LINK

8011314

ATOMOXETINE CAP 60MG

SEE ABOVE LINK

8011322

ATOMOXETINE CAP 80MG

SEE ABOVE LINK

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.

SUB-TYPE: CLASS 4 CAUTION IN USE

Class 4 caution in use-Grepid 75mg tablets

PHARMATHEN S.A. has informed the MHRA that the outer carton (box) of some batches of Grepid 75mg film coated tablets is missing the medicines legal classification for a Prescription Only Medicine ‘POM.’ This notification contains additional batches impacted by this issue.

 

MHRA Drug alert date: 24th June 2024

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-pharmathen-s-dot-a-grepid-75-mg-film-coated-tablets-kent-pharma-livery-el-24-a-slash-24?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=f15adf5b-de21-4835-8382-afc63f6af7a2&utm_content=immediately

 

 

Pip code

Product description

Supplier

Batch Numbers

ALLIANCE DO NOT STOCK

Grepid 75 mg film coated tablets

PHARMATHEN S.A

SEE ABOVE LINK

 

 

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

 

Further Information

For more information, medical or supply enquiries, please contact telephone: +30 210 6604300 or via email: pharmacovigilance@pharmathen.com & info@pharmathen.com

 

 

SUB-TYPE: CLASS 3 RECALL

Class 3 recall-GoResp Digihaler

Teva UK Limited has informed the MHRA that it plans to withdraw from further sale all batches of GoResp Digihaler (budesonide and formoterol fumarate dihydrate) and the linked Digihaler App for commercial reasons.

MHRA Drug alert link: https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-teva-uk-limited-goresp-digihaler-el-24-a-slash-23?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=9edb0dde-bbc2-4ee4-8039-9d803a602c9c&utm_content=immediately

 

Pip code

Product description

Supplier

Batch Numbers

4250197

GORESP DIGIHALER 160/4.5MCG GB

TEVA UK LTD

ALL

4250080

GORESP DIGIHALER 320/9MCG (GB)

TEVA UK LTD

ALL

 

 

 

Further Information

For medical information, please contact medinfo@tevauk.com (Tel. 02075 407117) and stock control enquiries please contact customer.services@tevauk.com (Tel. 0800 590502).

 

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 Caution in use- Oxcarbazepine Mylan 150 mg, 300mg, 600mg Film-Coated Tablets

Viatris UK Healthcare Limited has informed the MHRA that the Patient Information Leaflet (PIL) packaged in the specified batches of Oxcarbazepine 150 mg, 300 mg & 600 mg Film-Coated Tablets do not contain the most up to date safety information.

 

MHRA Drug alert date: 17th June 2024

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-viatris-uk-healthcare-ltd-oxcarbazepine-mylan-150-mg-300mg-600mg-film-coated-tablets-el-24-a-slash-22

 

Pip code

Product description

Supplier

Batch Numbers

1135763

OXCARBAZEPINE TAB 150MG MYL

VIATRIS

A4659   A4660

1135755

OXCARBAZEPINE TAB 300MG MYL

VIATRIS

N3560   A4705

1135748

OXCARBAZEPINE TAB 600MG MYL

VIATRIS

M3556

 

 

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

 

Further Information

For medical information and stock control queries please contact:

Viatris UK Healthcare Limited Medical Information at +44 (0)1707 853 000 (select option 1) or info.uk@viatris.com. Customer Services can be reached at +44 (0)1707 853 000 (select option 2).

SUB-TYPE: FIELD SAFETY NOTICE

Field Safety notice-Tegaderm - Transparent Film Dressing Frame Style

We have received a recall notice from 3M regarding two batches of Tegaderm Transparent film dressings

 

Date of recall: 31/05/24

 

Pip code

Product description

Supplier

Batch Numbers

2428951

TEGADERM 1632P-10 DRSG 12CMSQ

3M

104841330  106615553

 

 

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 caution in use-Paracetamol 500mg, 1000mg Film-Coated Tablets Drugs R Us

Dawa Limited has informed the MHRA that specified batches listed in this notification have been packed with an outdated Patient Information Leaflet (PIL).

 

MHRA Drug alert date: 10th June 2024

MHRA drug alert link  https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-dawa-limited-paracetamol-500mg-1000mg-film-coated-tablets-el-24-a-slash-21

 

Pip code

Product description

Supplier

Batch Numbers

8055493

PARACETAMOL FC TAB 1000MG

DRUGS R US LTD (GENERICS)

220106

6835102

PARACET TAB (CAPL) 500MG ALM

DRUGS R US LTD (GENERICS)

220103  220105

 

 

 

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

 

Further Information

For more information, medical information and stock control queries please contact Drugsrus Limited (distributor) on 020 8423 3800 or email info@drugsrus.co.uk.