Medications & Supplements/Prescription Drugs

KVK-Tech, Inc.: Oxybutynin Chloride Tablets Recalled for Incorrect Bar Code Labeling

Agency Publication Date: December 19, 2018

Summary

KVK-Tech, Inc. is recalling 156 bottles of Oxybutynin Chloride Tablets (5 mg), a prescription medication used to treat overactive bladder. The recall was initiated because the 500-count bottles were labeled with the wrong bar code, which could lead to medication errors during dispensing. These products were distributed to 10 major distributors throughout the United States and can be identified by NDC 10702-201-50 and lot number 15079A.

Risk

The incorrect bar code on the bottle label may cause a pharmacist to dispense the wrong medication or dosage if they rely on scanning the bar code for verification. This increases the risk of a patient receiving the wrong drug, potentially leading to untreated symptoms or adverse side effects.

What You Should Do

Check your prescription bottle for Oxybutynin Chloride Tablets, USP, 5 mg in a 500-count bottle with NDC 10702-201-50.
Verify if your bottle matches lot number 15079A with an expiration date of 10/20.
Contact your healthcare provider or pharmacist immediately for guidance if you believe you have received medication from an affected bottle.
Return any unused product to the pharmacy where you purchased it for a refund.
Contact KVK-Tech, Inc. at their Newtown, PA facility for further instructions regarding this recall.
For additional questions, 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

Product return and pharmacist consultation

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

Affected Products

Product: Oxybutynin Chloride Tablets, USP, 5 mg (500-count bottle)

Model:

NDC 10702-201-50

Recall #: D-0340-2019

Lot Numbers:

15079A (Exp 10/20)

Date Ranges: Exp 10/20

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81804

Status: Resolved

Manufacturer: KVK-Tech, Inc.

Sold By: 10 major distributors

Manufactured In: United States

Units Affected: 156 bottles

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 for Oxybutynin Chloride Tablets, USP, 5 mg in a 500-count bottle with NDC 10702-201-50.

Verify if your bottle matches lot number 15079A with an expiration date of 10/20.

Contact your healthcare provider or pharmacist immediately for guidance if you believe you have received medication from an affected bottle.

Return any unused product to the pharmacy where you purchased it for a refund.

Contact KVK-Tech, Inc. at their Newtown, PA facility for further instructions regarding this recall.

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