Medications & Supplements/Prescription Drugs

NCS Healthcare of Kentucky Inc: Glycopyrrolate Tablets Recalled for High Impurity Levels

Agency Publication Date: February 18, 2020

Summary

NCS Healthcare of Kentucky Inc. is recalling 6,929 blister cards of Glycopyrrolate tablets (1 mg) because they failed quality testing for impurities and degradation. These prescription medications, packaged by Vangard for institutional use, were found to have an unknown impurity that exceeds safe specifications. Consumers or healthcare facilities with this medication should immediately identify if their tablets are part of the affected lot, as the presence of unknown impurities can affect the drug's safety and effectiveness.

Risk

The tablets contain a high level of an unknown impurity that exceeds specified safety limits, which could potentially cause unexpected side effects or reduce the clinical effectiveness of the medication.

What You Should Do

Check your medication packaging for Glycopyrrolate Tablets, USP, 1 mg, in 30-count unit dose blister cards labeled 'FOR INSTITUTIONAL USE ONLY' and packaged by Vangard.
Verify if your medication belongs to Lot # 8170-9004 with an expiration date of 01/2020. You can also identify the product by NDC number 0615-8170-39.
Immediately stop using any tablets from the affected lot and set them aside to ensure they are not administered to patients.
Contact your healthcare provider or pharmacist for guidance regarding alternative treatments and to report the possession of recalled medication.
Return any unused blister cards to the pharmacy or place of purchase for a refund and contact NCS Healthcare of Kentucky Inc. for further instructions.
For additional questions 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

Full Refund

Healthcare provider consultation and pharmacy refund.

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

Affected Products

Product: Glycopyrrolate Tabs, USP, 1 mg (30-count unit dose blister card)

Model:

NDC 0615-8170-39

Recall #: D-0850-2020

Lot Numbers:

8170-9004 (Exp 01/2020)

Date Ranges: Expiration Date: 01/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84992

Status: Resolved

Manufacturer: NCS Healthcare of Kentucky Inc

Sold By: Institutional healthcare facilities

Manufactured In: United States

Units Affected: 6929 blister cards

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 medication packaging for Glycopyrrolate Tablets, USP, 1 mg, in 30-count unit dose blister cards labeled 'FOR INSTITUTIONAL USE ONLY' and packaged by Vangard.

Verify if your medication belongs to Lot # 8170-9004 with an expiration date of 01/2020. You can also identify the product by NDC number 0615-8170-39.

Immediately stop using any tablets from the affected lot and set them aside to ensure they are not administered to patients.

Contact your healthcare provider or pharmacist for guidance regarding alternative treatments and to report the possession of recalled medication.

Return any unused blister cards to the pharmacy or place of purchase for a refund and contact NCS Healthcare of Kentucky Inc. for further instructions.

For additional questions 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.