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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Takeda Development Center Americas, Inc.: Actoplus met XR Recalled for Defective Tablet Delivery System

Agency Publication Date: October 11, 2018
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Summary

Approximately 7,248 bottles of Actoplus met XR (pioglitazone and metformin HCl, extended-release) tablets are being recalled because the tablets may be missing the laser-drilled holes required for the metformin core to release medication properly. This defect can prevent the medication from being delivered to the patient as intended. This recall affects 30-count bottles of the 15 mg/1000 mg strength distributed in several U.S. states and Puerto Rico.

Risk

The missing or partial laser-drilled holes on the tablet core can lead to an ineffective delivery of the medication, which may result in poor blood sugar control for patients with type 2 diabetes.

What You Should Do

  1. Check your medication bottle to see if it is Actoplus met XR (pioglitazone and metformin HCl, extended-release) tablets, 15 mg/1000 mg, in a 30-count bottle.
  2. Verify the identifying codes on your bottle: look for NDC 64764-510-30 and lot numbers A26004 (expiring April 2020), A26443 (expiring September 2020), or A26444 (expiring September 2020).
  3. Contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription if your bottle is part of this recall.
  4. Return any unused or affected medication to your pharmacy to receive a refund and for proper disposal instructions.
  5. Contact Takeda Pharmaceuticals America, Inc. at their Deerfield, Illinois location if you have specific questions regarding this manufacturing defect.
  6. For further information or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Pharmacy refund and healthcare consultation

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Actoplus met XR (pioglitazone and metformin HCl, extended-release) tablets (30-count bottle)
Model:
NDC: 64764-510-30
Recall #: D-0026-2019
Lot Numbers:
A26004 (exp Apr 2020)
A26443 (exp Sep 2020)
A26444 (exp Sep 2020)
Date Ranges: April 2020, September 2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80964
Status: Resolved
Manufacturer: Takeda Development Center Americas, Inc.
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 7,248 bottles
Distributed To: Arkansas, Louisiana, Mississippi, North Carolina, New Jersey, Ohio, Pennsylvania, South Carolina, Puerto Rico
Agency Last Updated: October 15, 2018

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.