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ampouleMarch 2 2016

Two batches of Maxolon (metoclopramide) 5mg/ml solution for injection 2ml ampoules have been recalled due to a printing error on the outer carton.

AMCo has issued the recall for the following batches:

Batch No Expiry Date Pack Size First Distributed
J001 April 2020 12 16/11/2015
J003 October 2020 12 21/01/2016

The MHRA said the recall was due to the outer carton incorrectly stating ‘administer prescribed dose either intramuscularly or by slow intravenous injection (1-2 minutes)’. “The correct instruction is that the intravenous injection should be administered over at least three minutes. The correct instruction is given in the patient information leaflet and the Summary of Product Characteristics.”

The advisory notes that in December a European Medicines Agency assessment report had concluded that intravenous doses should be administered as a slow bolus over at least three minutes to reduce the risk of adverse effects.

“Metoclopramide has long been associated with a risk of serious neurological adverse reactions such as acute extrapyramidal symptoms and irreversible tardive dyskinesia. The slow administration of intravenous doses as a slow bolus over at least 3 minutes lowers the risk of all dystonic reactions,” said the MHRA.

“Older batches not included in the recall also have the old wording for the administration time; these were covered by a letter to healthcare professionals informing them of the new advice. The MHRA/CHM advice is also given in the BNF.”

Pharmacists have been advised to return any affected items to the supplying wholesaler. AMco can be contacted on 08700 70 30 33 for medical information inquiries or 0870 887 7025 for customer services.

The alert has been circulated in Scotland by the Healthcare Quality and Strategy Directorate.


MHRA announcement

Scottish announcement

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