D-0026-2019 Class II Terminated
FDA drug recall D-0026-2019 was initiated by Takeda Development Center Americas, Inc. on September 10, 2018 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated April 13, 2020). Affected quantity: 7,248 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- October 17, 2018
- Initiation Date
- September 10, 2018
- Termination Date
- April 13, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,248 bottles
Product Description
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
Reason for Recall
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.
Distribution Pattern
AR, LA, MS, NC, NJ, OH, PA, SC and Puerto Rico
Code Information
Lot, expiry: A26004, exp Apr 2020; A26443 and A26444, exp Sep 2020