Maxolon 5mg/ml, solution for injection, 2ml ampoules PL 20072/0051
AMCo are recalling the listed batches of Maxolon 5mg/ml as the outer carton contains incorrect administration instructions.
Product information
EL number
EL (16)A/02
MDR number
MDR 079-02/16
Company name
AMCo
Product description
Maxolon 5mg/ml, solution for injection, 2ml ampoules (Metoclopramide)
PL 20072/0051
Batch number/expiry
- Batch number: J001
- Expiry date: Apr 2020
- Pack size: 12
- First distributed: 16/11/2015
- Batch number: J003
- Expiry date: Oct 2020
- Pack size: 12
- First distributed: 21/01/2016
Brief description of the problem
AMCo are recalling the listed batches as the outer carton incorrectly states ‘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.
Pharmacists are asked to return any stock of the listed batches to the supplying wholesaler.
Advice for healthcare professionals and patients
On 20th December 2013, EMEA published an Article 31 Assessment Report (EMA/13239/2014). This concluded that intravenous doses should be administered as a slow bolus over at least 3 minutes to reduce the risk of adverse effects.
As assessed by EMEA, 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. If you experience any other side-effects, or have any questions or concerns about your health, speak to your doctor, pharmacist, or other healthcare professional.
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.
Any suspected side effects can be reported to MHRA through our medicines safety monitoring system, the Yellow Card Scheme or through the Yellow Card app available on iOS or Android.
Company contact for medical information enquiries
AMCo Medical Information:
Telephone: 08700 70 30 33
Email: medicalinformation@amcolimited.com
Company contact for stock enquiries
AMCo Customer Services:
Telephone: 0870 887 7025
Email: customercare@amcolimited.com
Download document
Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. Local area teams are asked to forward this to relevant clinics, general practitioners and community pharmacists for information.
Last updated 1 March 2016 + show all updates
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Under advice for healthcare professionals and patients, added clarification around added batches not included in the recall.
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First published.