Ticker Update

Field Safety Notice Activheal® Hydrogel 8g

AMS has identified that due to a tube quality issue that was determined during the manufacturing process, the sterility of a small number of the Affected Tubes may have been compromised. Investigations have determined a potential root cause and AMS are confident that the quality issue only affects the Affected Tubes and is not present in other batches of the ACTIVHEAL® Hydrogel product

The affected products' details are as follows:

This is an NWOS only recall and Alliance will not be accepting stock returns. Please contact Advanced Medical Solutions for further information

For further information regarding this Field Safety Notice Please contact Teresa Starkey at Advanced Medical Solutions. Email: Teresa.starkey@admedsol.com Tel: +441606 545617

Recipients of this Drug Alert should bring it to the attention of relevant contacts.

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

Class 2 Recall on Epilim 500mg Ec Tabs

Sanofi is recalling the above batches of product as a precautionary measure due to out of specification results for disintegration test during routine stability testing.

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

Class 3 Recall on Metoprolol 50 Mg Tablets

Accord Healthcare Ltd has informed us of an issue related to decommissioning of the above batches. Upon decommissioning at the pharmacy, there have been reports stating that when scanning the serialised 2D code, the status of packs may report as ‘EXPORT.' Although there is no risk to product quality, any remaining stock should be quarantined and returned.

Class 2 Recall on Boots Dermacare 1% W/W Hydrocortisone Ointment (P)

The Boots Company PLC has informed us that retained samples of the affected batch showed presence of Pseudomonas aeruginosa and are recalling the above batch as a precautionary measure. This product is only sold or dispensed from Boots stores and Boots online pharmacy.

Class 2 FMD Recall on Vimpat 100mg Tablets & Neupro 4mg/24 Hour Transdermal Patches

We have been notified of an issue whereby several affected batches of the products from the parallel distributors (repackers) in the link below have been found to have mismatched unique pack numbers on the Bollino label (a security and safety feature on the outer packaging). The unique pack numbers on the bollino label should be identical.

Class 4 Caution in Use on Zopiclone 3.75mg & 7.5mg Tablets

Ratiopharm UK Limited and Generics [UK] Limited t/a Mylan have confirmed that the Patient Information Leaflet (PIL) within all packs and the Summary of Product Characteristics (SmPC) for Ratiopharm is missing important safety information related to potential suicide risks.

Please visit the: MHRA website for more details on this drug alert.

The affected products' details are as follows:

PIP CodeProduct DescriptionLiveryAffected Batch

1110980ZOPICLONE TAB 3.75MGRatiopharm UK Limited and Generics [UK] Limited t/a MylanALL STOCK

1073626ZOPICLONE TAB 3.75MGRatiopharm UK Limited and Generics [UK] Limited t/a MylanALL STOCK

1076074ZOPICLONE TAB 3.75MGRatiopharm UK Limited and Generics [UK] Limited t/a MylanALL STOCK

1073584ZOPICLONE TAB 7.5MGGenerics [UK] Limited t/a MylanALL STOCK

1110998ZOPICLONE TAB 7.5MGGenerics [UK] Limited t/a MylanALL STOCK

1073618ZOPICLONE TAB 7.5MGGenerics [UK] Limited t/a MylanALL STOCK

8094740ZOPICLONE TAB 3.75MGRatiopharm UK Limited and Generics [UK] Limited t/a MylanALL STOCK

8094757ZOPICLONE TAB 7.5MGGenerics [UK] Limited t/a MylanALL STOCK

For more information or medical information queries, please contact: Ratiopharm UK Limited Teva UK Medical Information at: medinfo@tevauk.com or Tel No: 0207 540 7117

Generics [UK] Limited t/a Mylan Medical Information Direct Line +44 (0)1707 853 000 select option 1, Customer Care direct lin+44 (0)1707 853 000 select option 2 or via Medical Information e-mail info@mylan.co.uk

Recipients of this Drug Alert should bring it to the attention of relevant contacts.

This may have been supplied by AHDL. Unfortunately we are not providing specific batch information you will be required to follow the instructions as per the drug alert.

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

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

Class 3 Recall on Amlodipine 10mg Tablets

Accord Healthcare Limited is recalling the below batch of Amlodipine 10mg Tablets as a precautionary measure due to out of specification results for tablet description, hardness and average weight obtained during stability testing.

Class 4 FMD Recall Various products

The MHRA is currently investigating an incident where several medicines appear to have left the legal supply chain and have then been re-introduced via Kingsley Specials Ltd WDA(H) 49276, who purchased from a company that does not hold a wholesale dealers authorisation and then sold it on to a number of other wholesalers.

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.

Company contacts for further information Smartway Pharmaceuticals Limited • Email: regulatory@smartwaypharma.co.uk • Telephone: 020 8545 7743 Drugsrus Limited • Email: recall@drugsrus.co.uk • Telephone: 020 3397 2347 Optimal Pharma Limited • Email: info@optimalpharma.co.uk • Telephone: 020 3884 0032

Class 2 Recall on Oxylan 40mg prolonged-release tablets

GL Pharma is recalling the above batch of Oxylan 40mg prolonged-release tablets due to out of specification results for dissolution obtained during routine stability testing.

Class 2 Recall on Fasturtec® 7.5 mg. 1.5 mg/ml

Sanofi has informed us of an Out Of Specification (OOS) result which was detected for Rasburicase enzyme activity according to a specific method and specifications for US market, at 12 months stability time point. Sanofi is recalling Fasturtec® 7.5 mg (Rasburicase) Solution for IV infusion - 7.5 mg/5 ml (Injectable powder in vial packaged with 5 ml solvent in ampoule), batch number A9306 as a precautionary measure.