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

FDA recall notice · announced October 17, 2018 · Takeda Development Center Americas

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

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.

Notes

Distribution: AR, LA, MS, NC, NJ, OH, PA, SC and Puerto Rico
Lot/code information: Lot, expiry: A26004, exp Apr 2020; A26443 and A26444, exp Sep 2020
Quantity: 7,248 bottles
Status: Terminated
Products in this recall event:
- 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: 647 (D-0026-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.