SUB-TYPE: CLASS 4 CAUTION IN USE
Quadrant Pharmaceuticals Limited have informed the MHRA of an error with the Patient Information Leaflets (PILs) that have been packaged in various parallel imported batches.
MHRA drug alert date: 12 September 2022
MHRA drug alert link:
Pip code | Product description | Supplier | Batch Numbers |
7042013 | PI BEZALIP MONO TABLETS 400MG (30) | QUADRANT PHARMACEUTICALS LIMITED | J3594 J3741 J3943 K0077 K0310 K0327 K0455 K0547 K0549 K0562 K2019 K1994 K2196 K2274 K2742 K2943 K3158 K3134 |
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 or supply enquiries, please contact radoslaw.bandomir@maxearn.co.uk or natalie.harrison@hallohealthcaregroup.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 2 RECALL
Hikma Pharmaceuticals USA Inc are recalling the above batches due to an out of specification result with related substances during testing for retain samples. This unlicensed medicine has been imported into the U.K. to meet the special need of individual patients.
MHRA drug alert date: 30 August 2022
MHRA drug alert link:
Pip code | Product Description | Supplier | Batch Numbers |
ALLIANCE DO NOT STOCK | LORAZEPAM 2MG/ML INJECTION (UNLICENSED MEDICINES) | HIKMA PHARMACEUTICALS USA INC | 070084 070126 080060 080091 |
ALLIANCE DO NOT STOCK | LORAZEPAM 4MG/ML INJECTION (UNLICENSED MEDICINES) | HIKMA PHARMACEUTICALS USA INC | 070096 |
Alliance do not stock the above products so we will not be accepting Customer returns on this recall.
Further Information
For more information or medical enquiries, please contact pv@hikma.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 2 RECALL
The Medicines and Healthcare products Regulatory Agency (MHRA) has been investigating a report of a falsification of the above product in the UK. The UK Marketing Authorisation Holder has confirmed that the batch above is falsified and has been supplied by unauthorised distributors to the UK.
MHRA drug alert date: 22 August 2022
Pip code | Product Description | Supplier | Batch Numbers |
ALLIANCE DO NOT STOCK | Dysport 500 Units Powder for Solution for Injection | Ipsen Limited | U14534 |
Alliance do not stock the above product so we will not be accepting Customer returns on this recall.
Further Information
For medical information enquiries, please contact Ipsen Limited at medinfo.uk-ie@ipsen.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
Further to a previous defect notification, Accord Healthcare have informed us of an error with the patient information leaflets (PILs) that have been packaged in the below additional batches of products. These were an older version of the PIL which did not include the most up to date safety information.
MHRA drug alert date: 17 August 2022
Pip code | Product description | Livery | Batch Numbers |
1220268 | Rosuvastatin 5 mg film-coated tablets | ACCORD HEALTHCARE LIMITED | P2102389 |
1220250 | Rosuvastatin 10 mg film-coated tablets | ACCORD HEALTHCARE LIMITED | P2103803 |
1220243 | Rosuvastatin 20 mg film-coated tablets | ACCORD HEALTHCARE LIMITED | P2104132 |
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 or medical information queries please contact: Accord Medical Information Department on 01271 385257, email medinfo@accord-healthcare.com.
For stock control queries, please contact: Accord Customer Services Team on 0800 373573
For updated PIL requests please contact contact@accord-healthcare.com or phone: 01271 385200
SUB-TYPE: CLASS 2 RECALL
Sun Pharmaceuticals are recalling the below batches of zoledronic acid due to out of specification results observed for Particulate Matter Test during routine stability testing. This recall is conducted as a precautionary measure as remaining vials may no longer be in line with the licensed product specification with respect to particulate matter.
MHRA drug alert date 11 August 2022
MHRA drug alert link:
Pip code | Product description | Livery | Batch Numbers |
1186964 | Zoledronic acid SUN 5mg solution for infusion | SUN PHARMA UK | JKX5541B |
Further Information
For more information, medical or supply enquiries, please contact:
Maciej Rosiak (Qualified Person), +31612091885; maciej.rosiak@sunpharma.com or
Gene Kelleher (Head Quality Europe), +353 86 344 1145; gene.kelleher@sunpharma.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: COMPANY-LED RECALL
Stockport Pharmaceuticals are recalling a batch of Sodium Chloride Eye Drops 5% w/v as the sterile eye droppers supplied with the medicinal product have expired (January 2022).
MHRA drug alert date: 8 August 2022
MHRA drug alert link:
Pip code | Product | Supplier | Affected Batches |
ALLIANCE DO NOT STOCK | Sodium Chloride Eye Drops 5% 1x10ml | Stockport Pharmaceuticals | C104308 |
Alliance do not stock this product and therefore we are not accepting stock returns.
Company Contact for medical information enquiries
For medical information enquiries, please contact:
Emma Joy Wraith
Head of Quality Assurance
Email: Emma-joy.wraith@stockport.nhs.uk
Company Contact for stock enquiries
For stock information enquiries, please contact:
Andrew Singleton
Head of Production
Email: Andrew.singleton@stockport.nhs.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.
SUB-TYPE: CLASS 1 RECALL
Clinigen Healthcare Ltd is initiating a recall of three batches of Mexiletine hydrochloride hard capsules due to a potential risk of underdose or overdose, which could have consequences for the safety of patients.
MHRA drug alert date: 4 August 2022
MHRA drug alert link:
Pip code | Product description | Livery | Batch Numbers |
8040990 | MEXILETINE CAP 50MG (84) | CLINIGEN HEALTHCARE LTD | 2111216 |
8041006 | MEXILETINE CAP 100MG (84) | CLINIGEN HEALTHCARE LTD | 2111217 |
8041014 | MEXILETINE CAP 200MG (100) | CLINIGEN HEALTHCARE LTD | 2111218 |
Further information
For more information or stock and resupply queries, please contact Quantum Pharmaceutical +44 (0) 1207 279 400 or email enquiries@quantumpharma.co.uk
For medical information queries, please contact Clinigen Medical Information on +44 (0) 1932 824 026 or email medicalinformation@clinigengroup.com
For all other enquires place contact Clinigen Healthcare Ltd on +44 (0) 1283 494 340 or email medicineaccess@clinigengroup.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
Omega Pharma Limited have identified an error relating to the product packaging. In the ‘Ingredients’ section on the base of the carton, the patch dosage is stated as providing 21mg of nicotine per day. The correct dosage is 14mg per day. The other dosage indications on the carton, the sachets, PIL and SmPC are correct. There is no issue with the product quality and the batch is not being recalled.
MHRA drug alert date: 20 July 2022
MHRA drug alert link:
Pip code | Product Description | Supplier | Batch Numbers |
4089983 | NIQUITIN PATCH CLEAR 14MG X 14 | OMEGA PHARMA LIMITED | 0370102 1110101 |
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: uklocustomerservice@perrigo.com
SUB-TYPE: CLASS 4 CAUTION IN USE
Novo Nordisk Limited would like to notify you of a defect that affects specific batches of NovoRapid FlexTouch prefilled pen device and batches of Saxenda FlexTouch prefilled pen device in the UK. The defect results in a non-functioning device where it is not possible to set a dose because the dose selector will spin freely, as such, click sounds will not be heard. Since a dose cannot be selected, the patient cannot inject a dose. A very small number of pens are affected – the average number of affected products is 2-3 pens per million pens. Based on the critical need for the products, they are not being recalled.
MHRA drug alert date: 21 July 2022
MHRA drug alert link:
Pip code | Product Description | Supplier | Batch Numbers |
3667698 | INS NOVORAPID FLEXTOUCH X 5 | NOVO NORDISK LIMITED | MZF0M05 MZF1H04 |
4154209 | SAXENDA 6MG/ML PREFILLED PEN 3ML X 3 | NOVO NORDISK LIMITED | LZF0H19 LZF0D36 LZFW142 MZF0V95 |
4028676 | SAXENDA 6MG/ML PREFILLED PEN 3ML X 5 | NOVO NORDISK LIMITED | LZFW572 LZF0D41 LZFW571 LZFY408 LZFY613 MZF1B51 |
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 Novo Nordisk Limited.
Further Information
For medical information and stock control queries please contact: Customer Care contact details +44 (0)800 023 2573 or CustomerCare@novonordisk.com
SUB-TYPE: CLASS 2 RECALL
Hameln pharma ltd is initiating a recall of batch 207506 of Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection/Infusion as a precautionary measure. This is due to an increased presence of visible crystalline particles within the solution, identified during ongoing re-inspection of retained samples.
MHRA drug alert date: 19 July 2022
MHRA drug alert link:
Pip code | Product Description | Supplier | Batch Numbers |
ALLIANCE DO NOT STOCK | AMIODARONE HYDROCHLORIDE 50 MG/ML CONCENTRATE FOR SOLUTION FOR INJECTION-INFUSION | HAMELN PHARMA LTD | 207506 |
Alliance do not stock the above product so we will not be accepting Customer returns on this recall.
Further Information
For more information or supply queries, please contact or email Hameln pharma ltd customer services on +44 (0)1452 621 661 or customer.services@hameln-pharma.co.uk
For medical information queries, please contact or email Hameln pharma ltd Medicines Information on +44 (0)1452 621 661 or drug.safety@hameln-pharma.co.uk