Medicines Healthcare Products Regulatory Agency
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 suppliers 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