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SUB-TYPE: CLASS 4 CAUTION IN USE

Class 4 Caution in use- Clexane 10,000 IU (100mg) / 1ml Syringes

Drugsrus Limited has informed the MHRA that the Patient Information Leaflet (PIL) packaged in specific batches of Clexane 10,000IU (100mg)/1 ml Syringes contains a typographical error in the leaflet.

 

MHRA drug alert date: 9th March 2023

 

MHRA drug alert link:  https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-drugsrus-limited-clexane-10000-iu-100mg-slash-1ml-syringes-el-23-a-slash-08

 

Pip code

Product

Supplier

Affected Batches

Alliance healthcare do not stock

Clexane 10,000IU (100mg)/1 ml Syringes

STAR PHARMACUETICALS LTD

ECD95D

Alliance healthcare do not stock

Clexane 10,000IU (100mg)/1 ml Syringes

TENOLOL LTD

ECI41A

FCA45G

 

 

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

 

Further Information

For more information, medical information queries or replacement PIL enquiries, please contact: recall@drugsrus.co.uk or 020 8423 3800. For stock control queries, please contact: info@drugsrus.co.uk or 020 8423 3800

SUB-TYPE: CLASS 4 CAUTION IN USE

Class 4 Caution in use- Methadone 1mg/mL Oral Solution BP Sugar Free and Methadone Mixture 1mg/ml

Thornton & Ross Ltd has informed the MHRA that specific batches of Methadone 1mg/mL Oral Solution BP Sugar Free and Methadone Mixture 1mg/ml, have been packaged with the incorrect Product Information Leaflet (PIL)

 

MHRA drug alert date: 7th March 2023

 

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-thornton-and-ross-ltd-methadone-1mg-slash-ml-oral-solution-bp-sugar-free-methadone-mixture-1mg-slash-ml-el-23-a-slash-07?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=5ef47bfe-e5f4-4643-8952-9a5fd54ed360&utm_content=immediately

 

Pip code

Product

Supplier

Affected Batches

1111103

METHADONE SF SOLN 1MG/ML T&R

THORNTON & ROSS

16LY
45LX
47LX
48LX
87MA
90MA
91MA
08MB
00MC
44MD
96MC
92MA
53MC
52MC
98MC
99MC
97MC

 

1074798

 

METHADONE MIXTURE 1MG/ML T&R

THORNTON & ROSS

 

19LY
17LY
18LY
21LY
20LY
47MB
19MB
16MB

 

 

 

 

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

 

Further Information

For medical information queries please contact thorntonross@medinformation.co.uk. Upon request, Thornton & Ross Ltd will provide hard copies of the updated PIL to pharmacy teams.

 

SUB-TYPE: CLASS 2 RECALL

Class 2 recall-Levothyroxine 12.5mcg tablets Teva

Reason: “Teva UK Limited is recalling the above batch of Levothyroxine 12.5mcg Tablets in response to a lower than required assay result discovered during routine stability testing.”

 

MHRA drug alert date  02 March 2023

 

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-teva-uk-limited-levothyroxine-12-dot-5mcg-tablets-el-23-a-slash-06?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=16a65f83-bc8f-4111-ab4d-5bbfef5ce896&utm_content=immediately

 

MHRA ref: MDR 226-02/23

 

 

Pip code

Product description

Livery

Batch Numbers

1212117

LEVOTHYROXINE 12.5MCG TABLETS

TEVA UK LTD

214052

 

Further Information

For any Levothyroxine stock enquiries please contact the Teva UK Limited Customer Solutions team on 0800 590 502.

 

For more information or medical enquiries, please contact Teva UK Limited by phone on 020 7540 7117 or by email to medinfo@tevauk.com

 

To report an adverse drug event to Teva UK Limited, please call 020 7540 7337, email uk.safety@tevauk.com or complete the online form at www.tevauk.com/Reporting-side-effects.

 

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- Zestoretic 20/12.5mg tablets

Atnahs Pharma UK has informed the MHRA that the Patient Information Leaflet (PIL) packaged in certain batches of Zestoretic 20mg/12.5mg Tablets contains outdated safety information

 

MHRA drug alert date: 27th February 2023

 

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-atnahs-pharma-uk-zestoretic-20mg-slash-12-dot-5mg-tablets-el-23-a-slash-05

 

Pip code

Product

Supplier

Affected Batches

0481044

ZESTORETIC 20/12.5MG TABLETS

Atnahs Pharma UK Ltd

SB012

 

 

 

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

 

Further Information

For more information, medical information queries, replacement PIL enquiries and stock control queries, please contact: info@pharmanovia.com

SUB-TYPE: CLASS 4 CAUTION IN USE

Class 4 Caution in use- Lemsip Max cold and flu capsules

Reckitt Benckiser Healthcare (UK) Limited has informed the MHRA that a typographical error has been identified on the end flap of the outer carton of some batches of Lemsip Max Cold & Flu Capsules.

 

MHRA drug alert date: 23rd February 2023

 

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-reckitt-benckiser-healthcare-uk-limited-lemsip-max-cold-and-flu-capsules-el-23-a-slash-04?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=c26db05c-8d64-472f-a107-53c53ded316e&utm_content=immediately

 

Pip code

Product

Supplier

Affected Batches

2531101

LEMSIP MAX COLD AND FLU CAPSULES (16)

RECKITT BENCKISER   

AED954
AED955
AED956
AED957
AED958
AED960
AED961

2531119

 

LEMSIP MAX COLD AND FLU CAPSULES (8)  

RECKITT BENCKISER   

AED981
AEE003

 

 

 

 

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

 

Further Information

For medical information and stock control queries please contact: ConsumerHealth_GB@Reckitt.com and / or 03332005345.

SUB-TYPE: FIELD SAFETY NOTICE

STOP DISTRIBUTION-EYECEE ONE PRELOADED & EYECEE ONE CRYSTAL PRELOADED INTRAOCULAR LENSES - ALLIANCE DO NOT STOCK

The MHRA is aware of reports of increased intraocular pressure in patients recently implanted with EyeCee One preloaded and EyeCee One Crystal preloaded intraocular lenses (IOLs).

 

MHRA drug alert date  26 January 2023

 

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/eyecee-one-preloaded-and-eyecee-one-crystal-preloaded-intraocular-lenses-iols-stop-using-immediately-and-quarantine-all-preloaded-eyecee-one-lenses-dsi-slash-2023-slash-001?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=e1e64c23-db14-4853-b96f-0ce8770935db&utm_content=immediately

 

Pip code

Product

Supplier

Affected Batches

ALLIANCE DO NOT STOCK

EyeCee One preloaded & EyeCee One Crystal preloaded intraocular lenses (IOLs)

BAUSCH AND LOMB

ALL BATCHES

 

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

 

 

Advice for patients

The advice in this notice is aimed at the healthcare teams who are responsible for providing and monitoring lenses used in cataract surgery. The MHRA is urgently investigating this issue and will be advising healthcare professionals on next steps, including the need to contact patients who may be affected, as soon as more information is available. If you are affected, your healthcare professional will contact you in due course. If you or somebody in your care had cataract surgery recently and are concerned, please contact the hospital where you had surgery for advice.

 

 

SUB-TYPE: CLASS 3 RECALL

CLASS 3 RECALL- LACIDIPINE 4MG TABLETS

Dr Reddy’s Laboratories (UK) Limited is recalling two batches of Lacidipine 4 mg Film-Coated Tablets as a precautionary measure due to the presence of an unknown solvent-like odour.

MHRA drug alert date: 18th January 2023

 

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-dr-reddys-laboratories-uk-ltd-lacidipine-4-mg-film-coated-tablets-el-23-a-slash-03?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=2e503df5-1891-40b4-a054-1dd7fb232117&utm_content=immediately

 

Pip code

Product description

Supplier

Batch Numbers

6833081

LACIDIPINE TAB 4MG

DR REDDY'S

B2202043

B2202044

 

Further Information

For medical information enquiries please contact Dr. Reddy’s Laboratories (UK) Ltd Medical Information Department at 01748 828873, or email drreddysGB@EU.ProPharmaGroup.com.

 

For stock control enquiries please contact Dr. Reddy’s Laboratories (UK) Ltd Customer Services Team at 01482 389858 (or main switchboard at 01482 860228), or email customerserviceuk@drreddys.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 - 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.