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.

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