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

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

Drug alert number: EL(22)A/37

Date issued: 30 August 2022

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 2 medicines recall for:

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.

Full drug alert can be viewed here.

Advice for patients

Patients are not required to take any action at this time. This product is administered by healthcare professionals only.

Further Information

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

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