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Update: Wockhardt UK Ltd - Amoxicillin Sodium 1g, 250mg and 500mg Powder for Solution for Injection

Medicines Healthcare Products Regulatory Agency

August 25
13:15 2020

Update (August 2020)

The advice relating to the drug alerts EL (14)A/09 and EL(15)A/11 has been updated. Please see details below; for reference the original alert details are still listed below.

In 2014, a Class 4 Drug Alert asked healthcare professionals not to use Wockhardt UKs Amoxicillin Sodium Powder for Solution for Injection (all strengths and all batches) in neonates and infants (below 1 year old) following reports of extravasation and injections site reactions; batches of the 500mg product were subsequently recalled.

Although no root cause has been confirmed for these events, an investigation identified contributing factors, which are currently considered to be resolved.

Based on MHRAs review of available data, the Commission on Human Medicines Paediatric Medicine Expert Advisory Group (PMEAG) has advised that Wockhardt UKs Amoxicillin Sodium Powder for Solution for Injection can be used with caution in neonates and infants.

Healthcare professionals are asked to exercise caution when using these products and monitor the cannula site before, during and after administration; administration should be stopped immediately if extravasation or injection site reactions are suspected and local guidelines followed.

Healthcare professionals should report extravasation events and any suspected adverse drug reactions with these products to the Yellow Card Scheme please include the suspected brand and batch number of amoxicillin sodium powder, if available.

Direct Healthcare Professional Communication

Alert from 10 November 2015

Class 4 caution in use

Distribute to pharmacy and hospital ward level

MDR 43-06/14

Product details

Wockhardt UK Ltd

Amoxicillin Sodium 250mg Powder for Solution for Injection - PL 29831/0010

Amoxicillin Sodium 500mg Powder for Solution for Injection - PL 29831/0012

Amoxicillin Sodium 1g Powder for Solution for Injection - PL 29831/0011

Alert details

Drug alert number EL (14)A/09 in connection with the above products was issued on 9 July 2014. Inthis alert, healthcare professionals treating neonates and infants (below one year old) were asked not touse Wockhardt Amoxicillin Powder for Solution for Injection (all strengths and all batches) in suchpatients. This was a precautionary measure following receipt of a number of reports of extravasationand injections site reactions.

Since a broader investigation of factors which may have caused this issue is now ongoing within MHRA, the recommendations in EL (14)A/09 are still applicable. An update will be provided should thesituation change. At this time, there is still no evidence to suggest that these products are defective.

Recipients of this drug alert should bring it to the attention of relevant contacts by copy of this letter.

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Wockhardt UK Ltd - Amoxicillin Sodium 1g, 250mg and 500mg Powder for Solution for Injection

Published 10 November 2015
Last updated 25 August 2020 +show all updates
  1. A data review has shown that Wockhardt UKs Amoxicillin Sodium Powder for Solution for Injection can be used with caution in neonates and infants

  2. First published.

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