Class 4 Drug Caution In Use - IBUPROFEN 400MG TABLETS

Flamingo Pharma UK Ltd have identified an error relating to the embossed batch number on some cartons of Ibuprofen 400mg tablets. The batch number is illegible on some cartons and poses a risk to traceability in the event of a future recall or a medical enquiry. The batch numbers on the blisters within the cartons are clear and present. Additionally, the expiry date is still visible and clearly marked on the carton and blister.

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-flamingo-pharma-uk-ltd-ibuprofen-400mg-tablets-el-22-a-slash-04?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=4e98e5c4-603a-4941-8d14-a508d8879d6f&utm_content=immediately

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

Further Information:

For medical information safety@flamingopharma.co.uk or general product enquiry sales@flamingopharma.co.uk +44 (0) 7733522465

Or

Mawdsley Brooks & Co Ltd

Overlabellingcustomerservices@mawdsleys.co.uk or 01302 553064

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

Class 4 Drug Caution in use - PIPERACILLIN/TAZOBACTAM 4 G/0.5G POWDER FOR SOLUTION FOR INFUSION

Antibiotice SA have identified an error on PIL of the below batches regarding the sodium content

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-antibiotice-sa-piperacillin-slash-tazobactam-4g-slash-0-dot-5-g-powder-for-solution-for-infusion-el-22-a-slash-03?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=5c74d887-61f6-4a04-b8a1-a44bdd00e295&utm_content=immediately

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

Further Information

For medical information please contact:

medical@antibiotice.ro

For stock control queries please contact:

shaunak@esteve.com

johnson@esteve.com

dromard@esteve.com

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

Class 4 Drug Caution in use - KABIVEN EMULSION FOR INFUSION

Fresenius Kabi Limited have identified an error in the infusion the infusion bag packaged into the below batches. In the list of ingredients section printed onto the bag, the amount of Glucose 19 %: Glucose (monohydrate) has been incorrectly declared as 110 g, the actual amount is 220g

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-fresenius-kabi-limited-kabiven-emulsion-for-infusion-el-22-a-slash-02?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=a03ef0f0-48bd-41ad-81db-62dc0b48b245&utm_content=immediately     

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

Further Information

For more information or medical information queries please contact: Medical.Information-UK@fresenius-kabi.com

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

CLASS 2 RECALL - IKERVIS EYE DROPS 0.1%

SANTEN Oy (trading as Santen UK Limited) are recalling the below batch of products as a precautionary measure due to detection of particles/crystals of the active pharmaceutical ingredient ciclosporin. These particles have been detected following microscopic evaluation during stability monitoring.

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-santen-oy-trading-as-santen-uk-limited-ikervis-1-mg-slash-ml-eye-drops-emulsion-el-22-a-slash-01?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=9afe2758-9d36-4cbd-86c2-bef85307f4a5&utm_content=immediately     

Alliance do not stock the above products so we will not be accepting Customer returns on this recall.

Further Information

Santen UK Limited

For more information, please contact +44 (0)1727 615 110 or email enquiries@santen.co.uk

For medical information queries, please contact 0345 075 4863 or email medinfo@santen.co.uk

For supply queries, please contact AAH Customer services at 0344 561 8899

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

Company Led Recall - Dermaved Sensitive Cream (Unlicensed Medicine)

Dermaved is recalling the above product from patients due to presence of clobetasol propionate (0.001% w/w). This product is supplied by Dermaved online.

The company’s investigation is on-going. Remaining stock of the above product should be returned to the company directly.

Clobetasol propionate is a strong steroid and it is an active ingredient in Prescription Only Medicines used for the treatment skin conditions such as psoriasis and eczema. Creams containing steroids should be used sparingly and as directed by the prescriber.

Although the presence of clobetasol propionate in this product is low, patients are advised to stop using the cream immediately, particularly pregnant and breastfeeding women, babies and young children.

There have been infrequent cases of skin reactions after stopping the use of creams containing steroids. Patients are advised to consult a doctor if their skin worsens within 2 weeks of stopping this cream or if they experience any side-effects from using this product. Suspected side effects should also be reported via the Yellow Card Scheme.

MHRA drug alert link: https://www.alliance-healthcare.co.uk/alliance-healthcare-news-updates?field_category_target_id=161 

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

Company contact for enquiries:

For more information, please contact Dermaved: info@dermaved.com

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

Class 4 Drug (Caution in use) - Benylin Chesty Coughs Original and Benylin Chesty Coughs Non-Drowsy

McNeil Products Limited have identified an error relating to the stated alcohol content for batches of Benylin Chesty Coughs Original (P) and Benylin Chesty Coughs Non-Drowsy (GSL) whereby the product labels understate the ethanol values. The products comply with the defined specifications, including ethanol content and, other than the incorrect ethanol content, all other label information is correct. However, the amount of ethanol contained within the products is low and hence the related on-pack safety warning, which reads “The small amount of alcohol in this medicine will not have any noticeable effects.”, is correct.

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-benylin-chesty-coughs-original-p-and-benylin-chesty-coughs-non-drowsy-gsl-el-21-a-slash-39?utm_medium=email&utm_campaign=govuk-notifications&utm_source=d42e0844-42e5-46ca-8471-2a82d76c7a4a&utm_content=immediately

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

Further Information:
For medical information queries please contact: McNeil Products Limited on 1344 864042 or by email to crc@its.jnj.com

Class 2 Recall - Heparin sodium 1,000 i.u./ml solution for injection or concentrate for solution for infusion

Wockhardt UK Ltd is recalling the above batch as a precautionary measure due to out of specification results due to a low bioassay result at the 24-month shelf life stability testing.

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-wockhardt-uk-ltd-heparin-sodium-1000-i-dot-u-slash-ml-solution-for-injection-or-concentrate-for-solution-for-infusion-el-21-a-slash-38?utm_medium=email&utm_campaign=govuk-notifications&utm_source=8c88aa6c-3295-4d61-b6ac-4b16836ec2d6&utm_content=immediately

Further Information

For more information or medical information queries, 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.

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

Class 4 Drug (Caution in use) - SmofKabiven Central emulsion for Infusion

Fresenius Kabi Limited have identified an error on the infusion bag packaged into the above batches. In the energy content section printed onto the bag the amount of carbohydrates (glucose anhydrous) has been incorrectly declared as 150g, the actual amount is 125g.

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-smofkabiven-central-emulsion-for-infusion-fresenius-kabi-ltd-el-21-a-slash-37?utm_medium=email&utm_campaign=govuk-notifications&utm_source=5a6a839e-bd5e-40f6-92dd-6c73adf4498f&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 contact:

Medical.Information-UK@fresenius-kabi.com

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

Company Led Recall - VITAMIN D3 DROPS

A quality issue has recently been identified in relation to the dispensing method used in the Vitamin D3 Drops for infants

MHRA drug alert link: N/A   

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.

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

CLASS 2 RECALL - MYDRILATE EY/D 0.5%

Intrapharm Laboratories Ltd are recalling the below batch of Mydrilate 0.5 % Eye Drops 5ml as a precautionary measure due to out of specification results for related substances obtained during stability testing

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-intrapharm-laboratories-ltd-mydrilate-0-dot-5-percent-eye-drops-5ml-el-21-a-slash-35?utm_medium=email&utm_campaign=govuk-notifications&utm_source=ae9c5b07-b1e0-4f64-bd26-24f1907b748f&utm_content=immediately

Further Information

For more information or medical information queries, please contact: Redline Pharmacovigilance, email: medinfo@intrapharmlabs.com, Contact number: 0330 1359 437

For stock control queries, please contact: Lauren Johnson, Commercial Affairs Manager, Intrapharm Laboratories Ltd, email: Lauren.Johnson@riemser.com; Landline: 01628 771800.

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.

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