Class 2

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

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

MDR Number: MDR 160-08/22

Company name: Hikma Pharmaceuticals USA Inc

Details of the affected batches:

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

Brief description of 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 to 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 to 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.

Company contacts for further information:

For more information or medical enquiries, please contact pv@hikma.com

To access the full recall: Class 2 Medicines Recall: Hikma Pharmaceuticals USA Inc, Lorazepam 2mg/ml Injection, Lorazepam 4mg/ml Injection (unlicensed medicines)