FDA-Drug2021-06-02Class II
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
Cardinal Health Inc.
Hazard
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Sold states
FL, GA, SC
Affected count
378 bottles
Manufactured in
7000 Cardinal Pl, N/A, Dublin, OH, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0436-2021Don't want to check this manually?
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