Update on Zantac solution for injection recall
24 October 2019
GSK has been contacted by regulatory authorities regarding the detection of NDMA in Zantac (ranitidine) products. We have been responding to the queries received from the regulatory authorities and continuing to work actively with them to address their concerns.
Based on information received to date and correspondence with regulatory authorities, GSK has made the decision to initiate a voluntary recall (pharmacy/retail level recall) of Zantac products in all markets as a precautionary action. This includes Zantac IV (injection) in New Zealand.
This recall action is being taken by GSK NZ after consultation with Medsafe and in line with the New Zealand Medicines and Medical Devices Recall Code procedure.
There may be instances where the benefits of using these medicines outweigh the risks associated with these recalls / product holds. Any decision not to comply with this recall and to hold stock for specific groups of patients is at the physician’s or pharmacy’s discretion. Any physician who has patients with a critical medical need for this product should contact GSK Customer Support at Mel.firstname.lastname@example.org or by phone 0800 877 789.
GSK is continuing with investigations into the potential source of the NDMA. These investigations include continued engagement with the API suppliers. GSK has engaged with external laboratories to conduct tests on API and finished product batches of Zantac.
Patient safety remains our utmost priority and we are taking this issue very seriously.
We are committed to supplying high-quality products to patients and sincerely regret any inconvenience caused to patients and healthcare professionals.