Product Defect Alert

HPS Pharmacies wish to advise that Accord Healthcare, in consultation with the Therapeutic Goods Administration (TGA), has given notice of a product defect alert for Methotrexate Accord vials as follows:

Methotrexate Accord Vials
Methotrexate 1000mg/10mL
ARTG 213737

This defect alert relates to a labelling anomaly. Old labelling states that the injection may be given by the intravenous, intramuscular, intra-arterial or intrathecal route. However, Accord Healthcare advises that it does not possess the data to support a route other than intravenous. This issue will be corrected with new labelling, as shown below.

Old labelling                                     New labelling

Accord Healthcare advises that Methotrexate Accord 1000mg/10mL injection vial  should only be administered intravenously. Administration via routes other than intravenous can lead to severe or even fatal neurotoxicity. No adverse events related to this labelling issue have been reported to date.

Retain this notice in a prominent position, including in other related business units for one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact Accord Healthcare on 1800 222 673, or your pharmacist at HPS Pharmacies.

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