[Response from the manufacturer:]
When the need to manufacture bupivacaine outside of Canada became a reality, our labelling capability was restricted to the manufacturing equipment at the new sourcing site. We made changes that we felt best accommodated the limitations of the labelling equipment and that we interpreted as acceptable for small labels. Of note, the generic name has always been included on the outer package.
Importantly, when we received concerns, we took measures to change the label. These included informing the Institute for Safe Medication Practices about the absence of the generic name on the Polyamp®, and working with our colleagues to make equipment modifications enabling the inclusion of the generic name. With regard to existing stock, we investigated the option of attaching pre-printed labels to the Polyamp®. This was considered unacceptable, as it could have compromised the safety of the product due to potential leaching of adhesive through the Polyamp® into the solution.
AstraZeneca collaborated with the Health Products and Food Branch Inspectorate to manage the existing product and the introduction of product with revised labelling. In addition, we alerted customers and Drug Information Centres regarding the introduction of product with revised labelling and the option to exchange existing stock. We also destroyed all of our stock with the previous labelling and replaced returned inventory with newly labelled product.