D-0026-2019 Class II Terminated

Recalled by Takeda Development Center Americas, Inc. — Deerfield, IL

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