- Medicines and Healthcare products Regulatory Agency
- 9 July 2014
- Alert type:
- Drug alert
- Medical specialty:
(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
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
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 firstname.lastname@example.org.
Recipients of this drug alert should bring it to the attention of relevant contacts by copy of this letter.
Issued: 9 July 2014
Alert type: Drug alert
Medical specialty: Pharmacy