Class 3 recall- OPDIVO 10 mg/mL concentrate for solution

Recalls and Alerts

Class 3 Recall

Class 3 recall- OPDIVO 10 mg/mL concentrate for solution

Bristol-Myers Squibb Pharmaceuticals Limited has informed the MHRA that a potential product quality issue has been detected, relating to incomplete crimping of the metal crimp cap of OPDIVO 10mg/mL concentrate for solution for infusion (nivolumab) (1VLX10ML)

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-bristol-myers-squibb-pharmaceuticals-limited-opdivo-10-mg-slash-ml-concentrate-for-solution-for-infusion-nivolumab-el-24-a-slash-11

Pip code	Product Description	Affected Batches
Alliance do not stock	OPDIVO 10 mg/mL concentrate for solution	8053520

Further information

For medical information enquiries please contact the Bristol Myers Squibb Medical Information Department by phone (0800 731 1736) or email medical.information@bms.com.

Please return all affected stock to your original supplier for credit. Unfortunately we can only accept stock purchased from us (Alliance Healthcare Distribution Limited). Any other stock will be returned to your stores/Pharmacies.

Please note that anything not returned to us, or notified to us, within 3 months of this notification, cannot be reimbursed by way of a credit.