Skip to content
Recall Observatory FDA recall evidence

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

August 06, 2018

Class II

Product summary

Firm
Teva Pharmaceuticals USA
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

    reason.no_named_rule · v1.0.0

    Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.