Drug product
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
D-0436-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 378 bottles
- Official record key
drug-enforcement:D-0436-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: ML0171
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations