Class 2 Medicines Recall: Hikma Pharmaceuticals USA Inc, Lorazepam 2mg/ml Injection, Lorazepam 4mg/ml Injection (unlicensed medicines), EL(22)A/37

Hikma Pharmaceuticals USA Inc are recalling the below batches due to an out of specification result with related substances during testing for retain samples.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 30 August 2022

• Message type: Medicines recall/notification
• Medical specialty: Anaesthetics, Cardiology, Care home staff, Cosmetic surgery and Critical care
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  Dentistry, Dispensing GP practices, General practice, General surgery, Haematology and oncology, Infection prevention, Obstetrics and gynaecology, Ophthalmology, Orthopaedics, Paediatrics, Pathology, Pharmacy, Physiotherapy and occupational therapy, Radiology, Renal medicine, Theatre practitioners, Urology, and Vascular and cardiac surgery
• Issued: 30 August 2022

MDR number

MDR 160-08/22

Company name

Hikma Pharmaceuticals USA Inc

Product name

Lorazepam 2mg/ml Injection, Unlicensed medicine

Batch number	Expiry date	Pack size	First distributed
070084	31 July 2023	25 x 1ml	17 August 2020
070126	31 July 2023	25 x 1ml	17 August 2020
080060	31 July 2023	25 x 1ml	17 August 2020
080091	31 July 2023	25 x 1ml	17 August 2020

Lorazepam 4mg/ml Injection, Unlicensed medicine

Batch number	Expiry date	Pack size	First distributed
070096	31 July 2023	25 x 1ml	17 August 2020

Active Pharmaceutical Ingredient: lorazepam

Brief description of the problem

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.

Advice for healthcare professionals

Stop supplying the above batch immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

Advice for patients

Patients are not required to take any action at this time. This product is administered by healthcare professionals only. If you have concerns about this notification, please contact your healthcare professional.

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.

Yours faithfully

Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU

Telephone +44 (0)20 3080 6574

DMRC@mhra.gov.uk

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Class 2 Medicines Recall: Hikma Pharmaceuticals USA Inc, Lorazepam 2mg/ml Injection, Lorazepam 4mg/ml Injection (unlicensed medicines), EL(22)A/37

Published 30 August 2022