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



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