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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

KVK-Tech, Inc.: Hydrocodone and Homatropine Tablets Recalled for Impurity Issues

Agency Publication Date: May 17, 2021
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Summary

KVK-Tech, Inc. has recalled 17,096 bottles of Hydrocodone Bitartrate and Homatropine Methylbromide (5 mg / 1.5 mg) tablets, a prescription medication used to treat cough. The recall was issued because the medication failed to meet approved quality standards for impurities and degradation levels. If you are taking this medication, you should consult your healthcare provider or pharmacist to discuss your treatment options and how to return the affected product.

Risk

The presence of impurities or chemical degradation beyond specified limits can make the medication less effective or potentially cause unintended side effects, although the risk level is currently classified as low.

What You Should Do

  1. Check your prescription bottle label to see if you have Hydrocodone Bitartrate and Homatropine Methylbromide tablets, USP, 5 mg / 1.5 mg in a 30-count bottle.
  2. Look for lot number 15684A with an expiration date of July 2021 (Exp 7/2021) and NDC 10702-055-03 printed on the label.
  3. If your medication matches these specific details, contact your healthcare provider or pharmacist immediately for guidance on continuing your treatment.
  4. Return any unused tablets from this lot to the pharmacy where you purchased them to receive a refund and ensure the product is disposed of properly.
  5. For further instructions, you may contact the manufacturer, KVK-Tech, Inc., located at 110 Terry Dr, Newtown, Pennsylvania, 18940-3427.
  6. If you have additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Pharmacy refund and consultation

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

Affected Products

Product: Hydrocodone Bitartrate and Homatropine Methylbromide tablets, USP, 5 mg/ 1.5 mg (30-count bottle)
Model:
NDC 10702-055-03
Lot Numbers:
15684A (Exp 7/2021)
Date Ranges: Expiration date 7/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87810
Status: Resolved
Manufacturer: KVK-Tech, Inc.
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 17,096 bottles
Distributed To: Nationwide

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.