Drug recall D-0436-2021
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
Reason for recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lots and codes
ML0171
Recall details
- Recalling firm
- Cardinal Health Inc., Dublin, OH
- Quantity
- 378 bottles
- Distribution
- FL, GA, SC
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 15, 2021
- Terminated
- June 17, 2024
Related products
- Xigduo – drug information
- NDC 0310-6270 Xigduo Xr · Dapagliflozin Propanediol 10 mg/1; Metformin Hydrochloride… · AstraZeneca Pharmaceuticals LP
- NDC 0310-6250 Xigduo Xr · Dapagliflozin Propanediol 5 mg/1; Metformin Hydrochloride… · AstraZeneca Pharmaceuticals LP
- NDC 0310-6260 Xigduo Xr · Dapagliflozin Propanediol 5 mg/1; Metformin Hydrochloride… · AstraZeneca Pharmaceuticals LP
- NDC 0310-6225 Xigduo Xr · Dapagliflozin Propanediol 2.5 mg/1; Metformin Hydrochloride… · AstraZeneca Pharmaceuticals LP
- NDC 0310-6280 Xigduo Xr · Dapagliflozin Propanediol 10 mg/1; Metformin Hydrochloride… · AstraZeneca Pharmaceuticals LP