Class 4 Medicines Defect Information: Sodium Benzoate (Amzoate) 2g in 10 mL Sterile Solution for injection (Torbay Pharmaceuticals (for Veriton Pharma Ltd))
Class 4 Medicines Defect Information: Sodium Benzoate (Amzoate) 2g in 10 mL Sterile Solution for injection (Torbay Pharmaceuticals (for Veriton Pharma Ltd))
May 28, 2020
Class 4 Medicines Defect Information: Sodium Benzoate (Amzoate) 2g in 10 mL Sterile Solution for injection (Torbay Pharmaceuticals (for Veriton Pharma Ltd))
Drug alert number: EL (20)A/24
Date issued: 28 May 2020
The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for:
Sodium Benzoate (Amzoate) 2g in 10 mL Sterile Solution for injection (Torbay Pharmaceuticals (for Veriton Pharma Ltd))
Torbay Pharmaceuticals has informed the MHRA that the carton label on Sodium Benzoate (Amzoate) 2g in 10mL Sterile Solution for injection incorrectly states the concentration of disodium edetate (excipient) as 0.1% w/v (10mg in 1mL) instead of 0.1% w/v (10mg in 10mL). It should be noted that this product is manufactured as an unlicensed special.
| 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 |
Advice for healthcare professionals
Healthcare professionals are advised to exercise caution when dispensing and administering the product. There is no risk to product quality as a result of this issue, therefore the associated batches are not being recalled at this time.
View full alert here
Further Information
For stock control queries please contact Torbay Pharmaceuticals, Telephone +44 (0)1803 664707 or email torbaypharmaceuticals@nhs.net
For any medical information enquires please contact Torbay Pharmaceuticals, Telephone +44 (0)1803 664707 or email torbaypharmaceuticals@nhs.net
Posted in: Dispensing & Supply, PSNC News
