Amoxicillin Sodium 500mg Powder for Solution for Injection - additional reports of injection site reactions in paediatrics and adults

(Wockhardt UK Ltd) Remaining stock from affected batches should be quarantined and returned to the original supplier for credit - class 2 action within 48 hours. (EL (14)A/11)

22 July 2014

Class 2 medicines recall

Action Within 48 Hours

Hospital pharmacy and ward-level recall

MDR 43-06/14

Product details

Wockhardt UK Ltd

Amoxicillin Sodium 500mg Powder for Solution for Injection

PL 29831/0012

Alert details

Batch number   Expiry date   Pack size   First distributed
1WA4002   31 Jan 2017   10 x 500mg   14 Apr 2014
1WA4003   31 Jan 2017   10 x 500mg   28 Feb 2014
1WA4004   31 Jan 2017   10 x 500mg   15 Apr 2014

Further to the Class 4 ‘caution in use’ Alert issued on 9 July 2014, ref. EL (14)A/09, Wockhardt UK Ltd has received a small number of additional reports of injection site reactions in both paediatrics and adults. As a precaution, the above batches of the 500mg presentation are now being recalled. The investigation by Wockhardt and its contract manufacturer in Italy is ongoing and at this time, there is no evidence to suggest that these batches are defective.

Remaining stock from the affected batches should be quarantined and returned to the original supplier for credit. For enquiries relating to stock returns please contact Wockhardt UK Ltd Customer Services on 01978 669215 or email customer.services@wockhardt.co.uk.

For medical information enquiries please contact Wockhardt UK Ltd Medical Information on 01978 661261 or email drug.safety@wockhardt.co.uk

Please note, the advice given in EL (14)A/09 still applies. That is, the following products (all batches) should not be administered to neonates or infants (below 1 year old) until further notice:

  • 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

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

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