xigduo XR (dapagliflozin/metformin HCl extended-release) tablets 5 mg/1000 mg 60 Tablets Rx only NDC 0310-6260-60 Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850
Recall Number: D-0436-2021
Firm: Cardinal Health Inc.
Classification: Class II
Status: Terminated
Report Date: 20210602
Initiation Date: 20210315
Termination Date: 20240617
Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Product Description
xigduo XR (dapagliflozin/metformin HCl extended-release) tablets 5 mg/1000 mg 60 Tablets Rx only NDC 0310-6260-60 Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850