Medications & Supplements/Prescription Drugs

KVK-Tech, Inc.: Hydrocodone/Homatropine Oral Solution Recalled for Foreign Black Particles

Agency Publication Date: November 13, 2019

Summary

KVK-Tech, Inc. is recalling approximately 1,534 bottles of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (5 mg/1.5 mg per 5 mL), a prescription medication used to treat cough. This recall was initiated after black particles were discovered in bottles during a routine inspection of stored samples. Using a product contaminated with foreign particles could lead to serious adverse health effects, particularly if the substance is ingested.

Risk

The presence of foreign black particles in an oral liquid medication poses a risk of choking, irritation, or localized infection if swallowed. For patients with underlying health conditions, consuming unidentified foreign matter may cause unforeseen systemic complications or toxic reactions.

What You Should Do

Check your 473 mL (1 pint) white plastic bottles of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution for NDC 10702-150-16.
Identify if your bottle is from Lot 14375A with an expiration date of 2019-DEC, or Lot 14398A with an expiration date of 2020-JAN.
If you have an affected bottle, stop using the medication immediately to avoid ingesting foreign particles.
Contact your healthcare provider or pharmacist for guidance on obtaining a safe replacement and to discuss any health concerns.
Return any unused product to the pharmacy where it was purchased for a refund and contact KVK-Tech, Inc. at 110 Terry Dr, Newtown, PA 18940 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 return.

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 Oral Solution 5 mg/1.5 mg per 5 mL (473 mL bottles)

Model:

NDC 10702-150-16

Lot Numbers:

14375A (Exp. date 2019-DEC)

14398A (Exp. date 2020-JAN)

Date Ranges: 2019-DEC, 2020-JAN

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84184

Status: Resolved

Manufacturer: KVK-Tech, Inc.

Sold By: pharmacies

Manufactured In: United States

Units Affected: 1534 bottles

Distributed To: Nationwide

Agency Last Updated: November 29, 2019

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 473 mL (1 pint) white plastic bottles of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution for NDC 10702-150-16.

Identify if your bottle is from Lot 14375A with an expiration date of 2019-DEC, or Lot 14398A with an expiration date of 2020-JAN.

If you have an affected bottle, stop using the medication immediately to avoid ingesting foreign particles.

Contact your healthcare provider or pharmacist for guidance on obtaining a safe replacement and to discuss any health concerns.

Return any unused product to the pharmacy where it was purchased for a refund and contact KVK-Tech, Inc. at 110 Terry Dr, Newtown, PA 18940 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.