Medications & Supplements/Prescription Drugs

Ascend Laboratories LLC: Quetiapine Tablets Recalled for Metal Shard Contamination

Agency Publication Date: November 28, 2018

Summary

Ascend Laboratories LLC is recalling one lot of Quetiapine (quetiapine fumarate) 400 mg tablets, a prescription medication used to treat certain mental and mood conditions. The recall was initiated because a metal shard was discovered embedded inside a tablet. Consumers should immediately check their 100-count bottles of this medication to see if they match the affected lot number and expiration date.

Risk

Ingesting a tablet containing a metal shard can cause physical injury to the mouth, throat, or digestive tract. It also poses a potential risk of internal bleeding or localized infection if the fragment becomes lodged in the body.

What You Should Do

Check your prescription bottle label for Quetiapine Tablets USP 400 mg in 100-count bottles.
Identify if your bottle is from Lot 7143908 with an expiration date of November 2020 (exp Nov 2020) and UPC code 3 67877-248-01 1.
If your medication matches this lot and expiration date, stop using it immediately and contact your healthcare provider or pharmacist for medical guidance and a replacement prescription.
Return any unused portion of the affected medication to the pharmacy where you purchased it for a refund.
Contact the manufacturer, Ascend Laboratories LLC, for further instructions on how to handle the recalled product.
For additional information or to report concerns, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

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

How to: Return the affected product to the place of purchase for a refund and consult a healthcare professional regarding alternative medication.

Affected Products

Product: Quetiapine Tablets USP 400 mg (100 tablet bottles)

Model:

NDC 67877-248-01

UPC Codes:

367877248011

Lot Numbers:

7143908 (Exp Nov 2020)

Date Ranges: November 2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81568

Status: Resolved

Manufacturer: Ascend Laboratories LLC

Sold By: Pharmacies; Hospitals

Manufactured In: India, United States

Distributed To: Nationwide

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 · 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.

Summary

What You Should Do

Check your prescription bottle label for Quetiapine Tablets USP 400 mg in 100-count bottles.

Identify if your bottle is from Lot 7143908 with an expiration date of November 2020 (exp Nov 2020) and UPC code 3 67877-248-01 1.

If your medication matches this lot and expiration date, stop using it immediately and contact your healthcare provider or pharmacist for medical guidance and a replacement prescription.

Return any unused portion of the affected medication to the pharmacy where you purchased it for a refund.

Contact the manufacturer, Ascend Laboratories LLC, for further instructions on how to handle the recalled product.

For additional information or to report concerns, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.