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.