PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: October 17, 2018 Initiated: September 10, 2018 #D-0026-2019

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.

Details

Units Affected
7,248 bottles
Distribution
AR, LA, MS, NC, NJ, OH, PA, SC and Puerto Rico
Location
Deerfield, IL

Frequently Asked Questions

What product was recalled?
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. Recalled by Takeda Development Center Americas, Inc.. Units affected: 7,248 bottles.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 17, 2018. Severity: Moderate. Recall number: D-0026-2019.