Umesh Modi is a chartered accountant, and Pamini Jatheeskumar is a chartered certified accountant at Silver Levene...
  Don Lavoie is alcohol programme manager at Public Health England and Gul Root is lead...
Don Lavoie is alcohol programme manager at Public Health England and Gul Root is lead pharmacist, Health and Wellbeing Directorate, Public Health England
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drug alertNovember 11 2015

‘Caution in use’ alerts relating to Primidone SERB 50mg tablets, distributed by Actavis, and Wockhardt’s Amoxicillin Powder for Solution for Injection have been issued.

 

The Class 4 drug alert for Primidone SERB 50mg tablets is due to the EAN barcode being incorrect. When scanned, it identifies the product as Primidone SERB 250mg tablets, not as 50mg tablets as stated correctly on all positions on the carton where it can be read.

The affected batches are:

Batch number Expiry date Pack size Livery First distributed
530689 Nov 2019 1 x 100 Laboratoire SERB 6 October 2015
531203 Jul 2020 1 x100 Laboratoire SERB n/a
531299 Aug 2020 1 x 100 Laboratoire SERB n/a


The Medicines and Healthcare products Regulatory Agency says there is no risk to product quality or patient safety resulting from this error. To avoid product shortages, batch 530689 is not being recalled, and the other two batches will continue to be distributed to keep the market supplied while the error is corrected. Stock control queries should be directed to Actavis Customer Services Team on 0800 373573.

The other Class 4 alert is for Wockhardt UK’s Amoxicillin Sodium 250mg, 500mg and 1g Powder for Solution for Injection. These should not be used for treating neonates and infants below one year old, advises the MHRA.

An alert was issued in July 2014 regarding the possibility of extravasation and injection site reactions occurring. “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,” says the MHRA.

“An update will be provided should the situation change. At this time, there is still no evidence to suggest that these products are defective.”

Links:

MHRA Primidone SERB 50mg alert

MHRA Amoxicillin Powder alert

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