September 2018 FDA Recall Drug by Takeda Development Center Americas, Inc.
D-0026-2019 - Defective Delivery System

This Class II drug recall was voluntarily initiated by Takeda Development Center Americas, Inc. on September 10, 2018 for the product Drug. The FDA reported the reason for recall as defective delivery system. The product was distributed in AR, LA, MS, NC, NJ, OH, PA, SC and Puerto Rico and the recall is currently terminated.

Recall Number: D-0026-2019

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.
Initiated
09-10-2018
Reported
10-17-2018
Quantity
7,248 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80964
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Takeda Development Center Americas, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
AR, LA, MS, NC, NJ, OH, PA, SC and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2020
Product Description About Product Description
Full technical description of 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

Batch or Lot Expiration Information

Lot# Lot, expiry: A26004, exp Apr 2020; A26443 and A26444, exp Sep 2020