Class 4 Medicines Defect Information: Sodium Benzoate (Amzoate) 2g in 10 mL Sterile Solution for injection, EL (20)A/24
Torbay Pharmaceuticals has informed us that the carton label on Sodium Benzoate (Amzoate) 2g in 10 mL 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).
MDR Number
MDR 101-05/20
Company name
Torbay Pharmaceuticals (for Veriton Pharma Ltd)
Product description
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 |
Brief description of the problem
Torbay Pharmaceuticals has informed us that the carton label on Sodium Benzoate (Amzoate) 2g in 10 mL 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.
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.
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
Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Download the attachment