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
