Other safety alerts
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| The United Kingdom: Class 4 Medicines Defect Information: Sodium Benzoate (Amzoate) 2g in 10 ml Sterile Solution for injection |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Torbay Pharmaceuticals has informed MHRA 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. The affected products are:
- Sodium Benzoate (Amzoate) 2g in 10 ml Sterile Solution for injection, Unlicensed Medicine - Y0260J - (MS) (batch number: 1902285, 1905165, 1907165)
- Sodium Benzoate (Amzoate) 2g in 10 ml Sterile Solution for injection, Unlicensed Medicine - Y9546K - (MIA) (batch number: 1807065, 1808065, 1808075, 1808245, 1812145)
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.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-sodium-benzoate-amzoate-2g-in-10-ml-sterile-solution-for-injection-el-20-a-24
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Friday, May 29, 2020
Issued at HKT 15:00
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