Amoxicillin Sodium 250mg, 500g, & 1mg powder for solution for injection - reports of extravasation and injection site reactions

(Wockhardt UK Ltd) Should not be used in neonates and infants under 1 year old until further notice. (EL (14)A/09)

09 July 2014

Class 4 medicines defect information

Caution in Use

Distribute to 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

Wockhardt UK Ltd has received a number of reports of extravasation and injection site reactions in neonates and infants (below 1 year old). As a precaution Wockhardt UK Ltd are asking all healthcare professionals treating neonates and infants not to use Wockhardt Amoxicillin Sodium Powder for Solution for Injection (all batches) in such patients until further notice, while the company investigates.

MHRA is working with Wockhardt UK Ltd to ensure these reports are investigated as quickly as possible. At this time there is no evidence to suggest that these products are defective.

For medical information enquiries please contact Wockhardt UK Ltd Medical Information on 01978 661261 or email

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

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Published 17 December 2014