Drug product
Actoplus met XR (pioglitazone and metformin HCl, extended-release) tablets, 15 mg/1000 mg, Rx Only, 30 tablet bottle, Distributed by: Takeda Pharmaceuticals America, Inc, Deerfield, IL 60015. NDC: 64764-510-30
D-0026-2019
Product summary
- Event
- Event 80964
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,248 bottles
- Official record key
drug-enforcement:D-0026-2019
Official wording
Reason: Defective Delivery System: tablets may be missing, in whole or in part, the laser drilled holes on the metformin core of the Actoplus met XR tablets.
Code information: Lot, expiry: A26004, exp Apr 2020; A26443 and A26444, exp Sep 2020
Distribution pattern: AR, LA, MS, NC, NJ, OH, PA, SC and Puerto Rico
Derived failure modes
-
Unknown
Defective Delivery System: tablets may be missing, in whole or in part, the laser drilled holes on the metformin core of the Actoplus met XR tablets.