PRODUCT QUALITY CONCERN: Dexmedetomidine Hydrochloride Injection 400 mcg/ 100 mL
Details:
Juno Pharmaceuticals Canada (JPC) is aware of a potential product quality concern with our Dexmedetomidine Hydrochloride Injection 4 mcg/mL (400 mcg/100mL) DIN 02487373, UPC/GTIN: 00841629000145. JPC has received 3 complaints from the Canadian market since November 2022 for this product.
The concern is specific to 2 market distributed finished goods lot AGB217 and lot AGB218 and involves the failure of the integrated vial hanging label.
The failure of the integrated vial hanging label may cause the vial to fall while hung during dosage administration.
Dexmedetomidine Hydrochloride Injection 4 mcg/mL is a Alpha2-adrenergic agonist and is a medical necessity.
The product is used as a first line therapy to achieve intensive care unit sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting.
The product is also used to achieve sedation of non-intubated patients prior to and/or during surgical and other procedures by continuous intravenous infusion.
JPC will provide an update on the resolution of the product quality concern to all HCP’s and buying groups as soon as we have concluded our investigation and implemented appropriate corrective and preventative actions.
For questions or to report a product quality concerns please contact our quality department at: Quality@junopharm.com, or, our medical information center at medinfo-PV@junopharm.com or 1-(866)-663-1747.
Mitigation Strategy.
To continue using the 100 mL fill format (400 mcg/100 mL), JPC is recommending that healthcare practitioners avoid using the integrated vial hanging tabs on the vial label and utilize plastic hangers for infusion bottles, where possible and available. We are also working with our suppliers to source and provide plastic hangers for use with the 100 mL fill format.
JPC has an alternate size format of Dexmedetomidine Hydrochloride Injection 4 mcg/mL presented as 200 mcg/50 mL in a ready to use formulation. JPC is requesting that buying groups and healthcare practitioners switch to the 50 mL fill format.
An additional alternative is available as Dexmedetomidine Hydrochloride for Injection USP, 100 mcg/mL which requires dilution prior to use.
Should you have any product availability questions please contact our sales team at: Sales@junopharm.com.
Thank you,
Mike Tersigni
JPC Quality Assurance Manager
