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SUB-TYPE: CLASS 4 CAUTION IN USE

Class 4 Drug Caution In Use - Depo-Medrone with Lidocaine 40 mg/mL (1 mL and 2 mL vials – single vial preparations)

Pfizer Limited have informed the MHRA that an outdated version of the Patient Information Leaflet (PIL) has been included in the packaging of the above mentioned batches of Depo-Medrone with Lidocaine (Methylprednisolone acetate and Lidocaine hydrochloride) 40 mg/mL 1 mL and 2 mL vials (single vial presentations) to the UK market.

 

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-pfizer-limited-depo-medrone-with-lidocaine-40-mg-slash-ml-1-ml-and-2-ml-vials-single-vial-preparations-el-22-a-slash-18?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=9485c83a-e291-4936-818f-71376a60455f&utm_content=immediately

 

Pip code

Product description

Supplier

Batch Numbers

2343036

DEPO MEDRONE LIDOCAIN 40MG/ML, 1ML

PFIZER LTD

EL4771

FK6842

294892

DEPO MEDRONE LIDOCAIN 40MG/ML, 2ML

PFIZER LTD

EK3997

FK6089

FN9557

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

 

Further Information
If you have any questions, please contact Pfizer Medical Information Department on 01304 616161

SUB-TYPE: CLASS 2 RECALL

Class 2 Recall - Olopatadine USV 1mg/mL eye drops 5ml

USV UK Limited are recalling specific batches of products as a precautionary measure due to out of specification results for impurities during routine stability testing.

 

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-usv-uk-limited-olopatadine-usv-1mg-slash-ml-eye-drops-solution-el-22-a-slash-17?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=fdc295a6-ab88-476f-954b-60c595629a00&utm_content=immediately

 

Pip code

Product description

Livery

Batch Numbers

8943771

OLOPATADINE USV 1MG-ML EYE DROPS 5ML

USV UK LIMITED

35000201

35000202

35000203

35000204

35000206

Further Information

 

For more information, medical or supply enquiries, please contact info@ennogen.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 - Accuretic 10/12.5 mg film-coated tablets

Pfizer Ltd are recalling batch number DD4842 as a precautionary measure due to the identification of a nitrosamine above the acceptable limit.

 

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-pfizer-limited-accuretic-10-slash-12-dot-5-mg-film-coated-tablets-el-22-a-slash-16?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=aa52a52c-2b0d-4e40-bcc1-82255ece8cd4&utm_content=immediately

 

Pip code

Product description

Supplier

Batch Number

64733

ACCURETIC TABLETS 10/12.5 X 28

PFIZER LTD

DD4842

Further Information

 

For medical information enquiries, please contact Pfizer Medical Information Department on 01304 616161

 

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 Drug Caution In Use - Benzylpenicillin benzathine 1.2 Million I.U. and 2.4 Million I.U. powder and solvent for suspension for injection

Brancaster Pharma Limited have notified us of an issue relating to the label of the Water for Injections (solvent) packaged in each finished product pack.

 

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-benzylpenicillin-benzathine-1-dot-2-million-iu-and-2-dot-4-million-iu-powder-and-solvent-for-suspension-for-injection-el-22-a-slash-15?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=0932503e-1ef9-44ca-ae54-31760eaacaf9&utm_content=immediately

 

Pip code

Product description

Supplier

Batch Numbers

1237783

BENZATHINE (BENZYLPEN) 1.2MILL IU

BRANCASTER PHARMA LTD

72C00215

72C00116

72N00206

1237791

BENZATHINE (BENZYLPEN) 2.4MILL IU

BRANCASTER PHARMA LTD

72C00216

72C00220

72C00223

72N00207

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

 

Further Information

For medical information and stock control queries please contact: safety@brancasterpharma.com

SUB-TYPE: COMPANY-LED RECALL

Company Led Recall - NETSPOT (Kit for the preparation of gallium Ga 68 dotatate injection) [unlicensed medicine]

Advanced Accelerator Applications is recalling specific batches of this product as a precautionary measure due to an out of specification result that was identified during stability testing.

 

MHRA drug alert link: 

https://www.gov.uk/drug-device-alerts/company-led-medicines-recall-advanced-accelerator-applications-netspot-kit-for-the-preparation-of-gallium-ga-68-dotatate-injection-unlicensed-medicine-clmr-22-a-slash-02?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=1f3d3fed-4932-4368-813d-6fcf6dd2ef00&utm_content=immediately

 

Pip code

Product

Supplier

Affected Batches

ALLIANCE DO NOT STOCK

NETSPOT (KIT FOR THE PREPARATION OF GALLIUM GA 68 DOTATATE INJECTION)

ADVANCED ACCELERATOR APPLICATIONS

PG1921014

PG1921015

PG1921017

PG1921018

PG1921028

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

 

Company contact for medical enquiries

For more medical information please contact Diane Fogarty: diana.fogarty@novartis.com

 

Company contact for stock enquiries

For more stock information please contact Jane Farr: jane.farr@novartis.com

SUB-TYPE: CLASS 4 CAUTION IN USE

Class 4 Drug Caution In Use - Beclometasone dipropionate 50 micrograms/dose Nasal Spray (Various Liveries)

Ayrton Saunders Limited have identified an error relating to the Braille printed on the cartons.

 

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-ayrton-saunders-limited-beclometasone-dipropionate-50-micrograms-slash-dose-nasal-spray-various-liveries-el-22-a-slash-14?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=3cee273e-9974-4dab-91dc-ef9076df844b&utm_content=immediately

 

Pip code

Product description

Supplier / Livery

Batch Numbers

ALLIANCE DO NOT STOCK

CAREWAY HAYFEVER RELIEF 50 MICROGRAMS/DOSE NASAL SPRAY

AYRTON SAUNDERS LIMITED

9F713

9K772

ALLIANCE DO NOT STOCK

CAREWAY HAYFEVER RELIEF FOR ADULTS 50 MICROGRAMS/DOSE NASAL SPRAY

AYRTON SAUNDERS LIMITED

9J739

ALLIANCE DO NOT STOCK

LLOYDS PHARMACY HAYFEVER RELIEF 50 MICROGRAMS/DOSE NASAL SPRAY

AYRTON SAUNDERS LIMITED

1B978

9H744

0F900

ALLIANCE DO NOT STOCK

TESCO ALLERGY RELIEF 50 MICROGRAMS/DOSE NASAL SPRAY

AYRTON SAUNDERS LIMITED

0G913

1C988

1B979

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

 

Further Information

For medical information and stock control queries please contact: Ayrton Saunders Ltd., 9 Arkwright Road, Astmoor Industrial Estate, Runcorn, Cheshire, WA7 1NU or quality@ayrtons.com

SUB-TYPE: CLASS 4 CAUTION IN USE

Class 4 Drug Caution In Use - Latuda film-coated tablets

CNX Therapeutics Ltd. have notified the MHRA that the batches of Latuda film-coated tablets listed in this notification will be released without EAN barcodes on the cartons.

 

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-cnx-therapeutics-ltd-latuda-film-coated-tablets-el-22-a-slash-13?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=dac1ea2a-e6e3-4479-b1e3-e8b6894509b8&utm_content=immediately

 

Pip code

Product description

Supplier

Batch Numbers

3884707

LATUDA 18.5MG TABLETS X 28

CNX THERAPEUTICS LTD

0011

0013

3884715

LATUDA 37MG TABLETS X 28

CNX THERAPEUTICS LTD

0020

0021

3884723

LATUDA 74MG TABLETS X 28

CNX THERAPEUTICS LTD

0029

0030

0031

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

 

Further Information

For more information and medical information contact: medinfo@cnx-therapeutics.com

 

For stock control queries please contact: supplychain@cnx-therapeutics.com

SUB-TYPE: CLASS 2 RECALL

Class 2 Recall - Diazepam Rectubes 2.5mg Rectal Solution

Wockhardt UK Ltd are recalling a batch of Diazepam RecTubes 2.5mg Rectal Solution due to an out of specification result for assay during routine stability testing.

 

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-wockhardt-uk-ltd-diazepam-rectubes-2-dot-5mg-rectal-solution-el-22-a-slash-11?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=ebb2ea59-2e04-4d36-ae96-7a763b1bac0f&utm_content=immediately

 

Pip code

Product description

Livery

Batch Numbers

2364925

DIAZEPAM RECTUBE 2.5MG

WOCKHARDT UK (TENDER)(MOV)

I55061

Further Information

 

For more information, medical or supply enquiries, please contact: drug.safety@wockhardt.co.uk

 

For stock control queries, please contact: customer.services@wockhardt.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.

SUB-TYPE: CLASS 3 RECALL

Class 3 Recall - Isotard 60mg XL Tablets X 28

Kyowa Kirin Services Ltd are recalling the below batch of Isotard 60mg XL Tablets as a precautionary measure due to microfibres/crystals of the Active Pharmaceutical Ingredient (API) being present on the surface of the tablets as a result of sublimation.

 

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-kyowa-kirin-services-ltd-isotard-60mg-xl-tablets-el-22-a-slash-10?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=b4f8ccdb-aa09-4628-ba52-819224d0c0b3&utm_content=immediately

 

Pip code

Product description

Livery

Batch Numbers

2240042

ISOTARD 60MG XL TABLETS X 28

KYOWA KIRIN (ALLFS)

1706875

 

Further Information

 

For more information please contact:

 

Customer Services for stock control enquiries: Karen Murray karen.murray@kyowakirin.com +44 (0) 7712 001288 (Mobile)

 

Quality enquiries Martin Smith martin.smith@kyowakirin.com +44 (0)7904 671 807 (Mobile)

 

or for Medical Information enquiries: medinfo@kyowakirin.com

 

For Adverse Event reporting: medinfo@kyowakirin.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 Drug Caution In Use - Naprosyn Tablets (All Strengths), Naprosyn EC 250mg Gastro-Resistant Tablets, Naprosyn EC 500mg Gastro-Resistant Tablets

Atnahs Pharma UK Limited have identified additional missing information on the PIL of the certain product batches.

 

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-atnahs-pharma-uk-limited-naprosyn-tablets-all-strengths-naprosyn-ec-500mg-gastro-resistant-tablets-el-22-a-slash-09?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=d1fe57c1-88a3-444b-acd2-2e861aa3fac2&utm_content=immediately

 

Pip code

Product description

Supplier / Livery

Batch Numbers

2434694

NAPROSYN TAB 250MG (56)

ATNAHS PHARMA UK LIMITED

E0098E5

E0098E6

E0102E1

E0102E2

E0103E1

0110130

NAPROSYN EC TAB 250MG (56)

ATNAHS PHARMA UK LIMITED

E0174E2

E0183E1

E0186E2

E0187E1

E0188E1

E0188E4

E0189E2

E0190E1

E0191E1

2200301

NAPROSYN TAB 500MG (56)

ATNAHS PHARMA UK LIMITED

E0962E1

E0963E1

E0964E1

E0965E2

E0972E1

E0973E1

E0974E1

E0975E1

0183459

NAPROSYN EC TAB 500MG (56)

ATNAHS PHARMA UK LIMITED

E0596E1

E0601E1

E0601E4

E0615E1

E0622E1

E0623E1

E0626E1

E0627E1

E0628E1

E0628E2

E0632E3

E0633E2

E0634E3

E0635E2

E0636E1

E0637E1

E0640E2

E0656E1

E0657E1

E0658E1

E0665E1

E0666E1

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

 

Further Information

For medical information queries or stock control queries, please contact: info@pharmanovia.com

 

If you have any questions, then please contact your local Service Centre Customer Services team.