Drug product
PIO&METFORMIN 15/1000 mg Tab 1 (Pioglitazone and Metformin XT) tablets, Takeda Brand Name: Actoplus Met XR (Pioglitazone and metformin HCl extended -release) tablets, 15 mg/1000 mg, packaged in a fiber drum, Application Holder Takeda Pharmaceuticals, U.S.A. Inc. One Takeda Parkway, Deerfield, IL 60015
D-0102-2019
Product summary
- Event
- Event 80790
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0102-2019
Official wording
Reason: Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Code information: Bulk Lot no 1250668, 15 mg/1000 mg Bulk product No # 1274150, no NDC Codes, bulk exp. date 05/2020 & 10/2020
Distribution pattern: Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.
Derived failure modes
-
Unknown
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.