GovWire

Class 4 Medicines Defect Information: Sodium Benzoate (Amzoate) 2g in 10 mL Sterile Solution for injection, EL (20)A/24

Medicines Healthcare Products Regulatory Agency

May 28
10:00 2020

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

Class 4 Medicines Defect Information: Sodium Benzoate (Amzoate) 2g in 10 mL Sterile Solution for injection

Published 28 May 2020

Recent Comments

Follow Us on Twitter

Share This


Enjoyed this? Why not share it with others if you've found it useful by using one of the tools below: