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Updates

SUB-TYPE: CLASS 2 RECALL

CLASS 2 RECALL - DIOCTYL CAPSULES 100MG (100 PACK)

Reason: “UCB Pharma Ltd is recalling the above batch of product as a precautionary measure due to the presence of a foreign capsule being found in a sealed pack. The Marketing Authorisation Holder’s investigation concluded that this was the result of a product mix up during the manufacturing process.

 

MHRA drug alert date  18 January 2023

 

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-ucb-pharma-ltd-dioctyl-100-mg-capsules-el-23-a-slash-02?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=5f2c6167-607e-4cbf-b15b-d3345054e3dc&utm_content=immediately

 

Pip code

Product description

Livery

Batch Numbers

0579409

DIOCTYL CAP 100MG (100 PACK)

UCB PHARMA LTD

322983D

 

Further Information

For more information, medical or supply enquiries, please contact UCB Pharma Ltd on (+44) 01753 777100 or 0800 279 3177 (freephone) or by email at UCBCares.UK@ucb.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 - BYLVAY 1200 MICROGRAMS HARD CAPSULES

 

Class 4 Drug Caution In Use - Bylvay 1200 Micrograms Hard Capsules

 

Albireo AB has informed the MHRA that there is a typographical error with the text on the side panel of the bottle label for a specific batch of Bylvay 1200 micrograms Hard Capsules.

 

MHRA drug alert date: 3rd January 2023

 

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-albireo-ab-bylvay-1200-micrograms-hard-capsules-el-23-a-slash-01?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=c026b52c-0482-46b8-aeef-c360417c08cf&utm_content=immediately 

 

Pip code

Product

Supplier

Affected Batches

ALLIANCE DO NOT STOCK

BYLVAY 1200 MICROGRAMS HARD     CAPSULES

ALBIREO AB

W067208E

 

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

 

Further Information

For medical information and stock control queries please contact: medinfo@Albireopharma.com

SUB-TYPE: CLASS 4 CAUTION IN USE

Class 4 Medicines Defect Information: Galderma (U.K.) Limited, Etrivex 500 micrograms/g Shampoo

Galderma (U.K.) Limited has informed the MHRA that the patient information leaflet (PIL) packaged in specific batches of Etrivex Shampoo is missing safety information

 

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-galderma-uk-limited-etrivex-500-micrograms-slash-g-shampoo-el-22-a-slash-51?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=90e00faf-8782-4c58-b00a-5c6c196d3cb8&utm_content=immediately

 

Pip code

Product description

Supplier

Batch Numbers

3281110

ETRIVEX SHAMPOO 500MCG/G

GALDERMA

0114291

0114277

0114252

This is a caution in use only we are not accepting stock returns - if any defective stock is found it should be returned directly to the manufacturer.

 

Further information

For more information, medical information queries or replacement PIL enquiries, please contact: medinfo.uk@galderma.com

For stock control queries, please contact: sales.uk@galderma.com

 

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.

 

SUB-TYPE: CLASS 4 CAUTION IN USE

Class 4 Medicines Defect Information: ADVANZ Pharma Ltd, MacroBID 100mg Prolonged-Release Capsules

ADVANZ PHARMA has made the MHRA aware that certain batches of MacroBID 100mg Prolonged-Release Capsules have been packed with the incorrect Patient Information Leaflet (PIL).

 

MHRA drug alert date: 5th December 2022

 

MHRA drug alert link:https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-advanz-pharma-macrobid-100mg-prolonged-release-capsules-el-22-a-slash-50?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=7dca1a8e-a797-4234-b6cb-7c92576fc0d0&utm_content=immediately

 

Pip code

Product description

Supplier

Batch Numbers

0941609

MACROBID CAP 100MG

AMCO / MERCURY PHARMA

21001

21002

21003

22001

22002

22003

22006

22007

This is a caution in use only we are not accepting stock returns - if any defective stock is found it should be returned directly to the manufacturer.

 

Further information

For further information, medical enquiries, stock information or request for printed copy of the associated SmPC, please contact telephone: + 44 (0) 208 5889 131 or via email: medicalinformation@advanzpharma.com.

 

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.

SUB-TYPE: CLASS 4 CAUTION IN USE

Class 4 Medicines Defect Information: Lucis Pharma Ltd, Oxycodone Hydrochloride 10mg/ml oral solution

Lucis Pharma Ltd has informed the MHRA that there is a typographical error with text on the rear side of the outer packaging for Oxycodone Hydrochloride 10mg/ml Oral Solution.

 

MHRA drug alert date: 29 November 2022

 

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-lucis-pharma-ltd-oxycodone-hydrochloride-10mg-slash-ml-oral-solution-el-22-a-slash-49?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=1864253f-7b0a-4b30-9aad-78ec2edb6c19&utm_content=immediately

Pip code

Product description

Supplier

Batch Numbers

ALLIANCE DO NOT SOCK

OXYCODONE HYROCHLORIDE 10MG/ML ORAL SOLUTION

LUCIS PHARMA LTD

21050004 

22080005

This is a caution in use only we are not accepting stock returns - if any defective stock is found it should be returned directly to the manufacturer.

 

Further information

For medical information and stock control queries please contact: enquiries@lucispharma.co.uk.

 

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.

SUB-TYPE: CLASS 4 CAUTION IN USE

Class 4 Medicines Defect Information: Martindale Pharma Venlafaxine 300mg XL Prolonged release tablets

 

Martindale Pharma has made the MHRA aware that the GTIN in the 2D barcode and the printed variable data represents the branded version of the product (Venlalic® XL 300 mg prolonged-release tablets).

 

MHRA drug alert date:  16 November 2022

 

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-macarthys-laboratories-t-slash-a-martindale-pharma-venlafaxine-xl-300-mg-prolonged-release-tablets-el-22-a-slash-47?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=499d8039-6eda-43fe-8884-9605b56b0d82&utm_content=immediately

 

 

Pip code

Product description

Supplier

Batch Numbers

8047318

1257559

8045320

VENLAFAXINE XL TAB 300MG

MARTINDALE PHARMA

LC69391

This is a caution in use only we are not accepting stock returns - if any defective stock is found it should be returned directly to the manufacturer.

 

Further Information

For further information, medical enquiries and stock information, contact: Licensed@ethypharm.com

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.

SUB-TYPE: CLASS 4 CAUTION IN USE

Class 4 Medicines Defect Information: PRENOXAD 1MG/ML INJECTION

Macarthys Laboratories (trading as Martindale Pharma, an Ethypharm Group Company), has notified the MHRA of a limited number of Prenoxad packs in a batch marketed in France with missing needles.

MHRA drug alert date: 10th November 2022

 

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/national-patient-safety-alert-class-4-medicines-defect-information-prenoxad-1mg-slash-ml-solution-for-injection-macarthys-laboratories-aurum-pharmaceuticals-ltd-slash-ethypharm-group-due-to-potential-missing-needles-in-sealed-kits

 

Pip code

Product description

Supplier

Batch Numbers

  3797131

  PRENOXAD 1MG/ML INJECTION

ETHYPHARM GROUP COMPANY

116917

119973

120140

125553

125555

125724

126941

126943

130203

130732

130843

134251

136031

136536

136551

137656

137768

138525

138904

139907

140236

141035

141812

141969

 

 

This is a caution in use only we are not accepting stock returns - if any defective stock is found it should be returned directly to the manufacturer.

 

Further Information

For more information on licensed stock and resupply queries for the licensed presentation, please contact licensed@ethypharm.com; telephone number: 0800 028 7933.

 

For medical information queries and all other enquiries, please contact medinfo@ethypharm.com; telephone number 01277 266 600.

 

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.

SUB-TYPE: COMPANY-LED RECALL

Company Led Recall-Activa Thigh Length Open Toe Hosiery class 2 XL size

L&R medical have informed us that on the affected batch of Activa Thigh Length Open Toe Hosiery XL the product inside the packaging is Small and not Extra Large

MHRA drug alert link: N/A   

PIP CODE

DESCRIPTION

SUPPLIER

AFFECTED BATCHES

2590883

ACTIVA T/L O/T C2 SND XL

L&R MEDICAL UK LTD

221909

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.

 

For more information please contact L&R MEDICAL UK LTD

customerservices@uk.lrmed.com

Quality&Regulatory@uk.lrmed.com

 

 

 

SUB-TYPE: CLASS 3 RECALL

Class 3 Recall - Mebeverine hydrochloride 135mg Film-coated Tablets

Medreich Plc UK is recalling the above batch as a precautionary measure due to out of specification results for tablet dissolution during routine product release testing.

 

MHRA drug alert date: 27th October 2022

 

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-medreich-plc-mebeverine-hydrochloride-135mg-film-coated-tablets-el-22-a-slash-46?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=0b5b7f21-3a71-444e-be6b-ea061980a229&utm_content=immediately

 

Pip code

Product description

Supplier

Batch Numbers

1152123

MEBEVERINE TAB 135MG

MEDREICH PLC

B11539

1037514

MEBEVERINE TAB 135MG

MEDREICH PLC

B11539

8113110

OTCD MEBEVERINE TAB 135MG

MEDREICH PLC

B11539

 

Further Information

For more information or supply enquiries, please contact Medreich PLC at cs_team@medreich.co.uk or by phone at 0208 831 1580, 0208 831 1511 or 0208 831 1509

For medical information queries, please contact pharmacovigilance@medreich.com

Recipients of this Medicines Recall 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.

 

SUB-TYPE: CLASS 4 CAUTION IN USE

Class 4 Medicines Defect Information: Recordati Rare Diseases, Pedea 5 mg/ml solution for injection

Recordati Rare Diseases T/A Recordati Rare Diseases UK Ltd has made the MHRA aware that specific batches of Pedea 5 mg/ml solution for injection have been packaged with the incorrect Product Information Leaflet (PIL).

 

MHRA drug alert date: 25th October 2022

 

MHRA drug alert link: 

https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-recordati-rare-diseases-pedea-5-mg-slash-ml-solution-for-injection-el-22-a-slash-45?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=8880eab9-9fb3-431a-85f0-7f29ba803bf5&utm_content=immediately

 

Pip code

Product description

Supplier

Batch Numbers

ALLIANCE DO NOT STOCK

PEDEA 5 MG/ML SOLUTION FOR INJECTION, 4 AMPOULES

RECORDATI RARE DISEASES T/A RECORDATI RARE DISEASES UK LTD

PD0G24E-07

PD0G24E-10

PF0G04E-03

This is a caution in use only we are not accepting stock returns - if any defective stock is found it should be returned directly to the manufacturer.

 

For further information, including medical enquiries and stock information, please contact:

Recordati Rare Diseases UK Ltd (local representative, WDA(H): 15720) on Tel: +44 (0)1491 414333 or +33 1 47 73 64 58 or email: RRDmedinfo@recordati.com

 

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 hospital pharmacists and pediatric doctors and nurses working in hospital setting for information.