Class 4 Drug Alert (caution in use): Amoxicillin Sodium 1g, 250mg and 500mg Powder for Solution for Injection (Wockhardt UK Ltd)
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Class 4 drug alert for Amoxicillin Sodium 1g, 250mg and 500mg Powder for Solution for Injection (Wockhardt UK Ltd).
This is because recommendations from a previous alert: “(Wockhardt UK Ltd) Should not be used in neonates and infants under 1 year old until further notice. (EL (14)A/09)” still stands. Healthcare professionals treating neonates and infants (below one year old) are advised not to use Wockhardt Amoxicillin Powder for Solution for Injection (all strengths and all batches) in such patients because there have been a number of reports of extravasation and injections site reactions.
Further details of the issue and action to take are available on the MHRA website.