The Medicines and Health products Regulatory Agency (MHRA) has issued a Class 4 Drug Alert for Sodium Benzoate (Amzoate) 2g in 10 ml Sterile Solution for injection.
Torbay Pharmaceuticals has informed the MHRA that the carton label on Sodium Benzoate 2g in 10ml Sterile Solution for injection incorrectly states the concentration of disodium edetate (excipient) as 0.1 per cent weight/value (w/v) (10mg in 1ml) instead of 0.1 per cent w/v (10mg in 10ml).
| Sodium Benzoate (Amzoate) 2g in 10 ml Sterile Solution for injection Unlicensed Medicine – Y0260J – (MS) | |||
| Batch Number | Expiry Date | Pack Size | First Distributed |
| 1902285 | 02/2022 | 10 | 04/04/2019 |
| 1905165 | 05/2022 | 10 | 08/07/2019 |
| 1907165 | 07/2022 | 10 | 18/09/2019 |
| Sodium Benzoate (Amzoate) 2g in 10 mL Sterile Solution for injection Unlicensed Medicine – Y9546K – (MIA) | |||
| Batch Number | Expiry Date | Pack Size | First Distributed |
| 1807065 | 07/2021 | 10 | 20/08/2018 |
| 1808065 | 08/2021 | 10 | 28/09/2018 |
| 1808075 | 08/2021 | 10 | 28/09/2018 |
| 1808245 | 08/2021 | 10 | 28/09/2018 |
| 1812145 | 12/2021 | 10 | 17/01/2019 |
Healthcare professionals are advised to exercise caution when dispensing and administering the product. The product is manufactured as an unlicensed special.
There is no risk to product quality as a result of this issue, therefore the associated batches are not being recalled at this time, the medicines defect information notice pointed out.
The community pharmacists have been suggested to contact Torbay Pharmaceuticals for any other information.
