Medications & Supplements/Prescription Drugs

West-Ward Columbus Inc: Oxcarbazepine Oral Suspension Recalled for Failed Impurity Specifications

Agency Publication Date: September 16, 2019

Summary

West-Ward Columbus Inc. has recalled 32,347 bottles of Oxcarbazepine Oral Suspension (300 mg/5 mL), an anti-seizure medication, because the product failed testing for impurities and degradation. This means the medicine may contain chemicals that should not be there or the active ingredient may have broken down, potentially making it less effective or causing unexpected side effects. The affected medication was distributed in 250 mL bottles across the United States and Puerto Rico.

Risk

The presence of impurities or degradation products beyond specified limits can reduce the medication's ability to control seizures and may introduce risks of toxic effects from the breakdown of chemicals within the oral suspension.

What You Should Do

Check your medicine bottle for Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL (250 mL per bottle) with the NDC number 0054-0199-59.
Verify if your bottle belongs to one of the affected lots: AA3957A (Expiration May 2020), AA3958A (Expiration May 2020), or AA5164A (Expiration September 2020).
Contact your healthcare provider or pharmacist immediately to discuss a replacement and to ensure your seizure management plan is not interrupted.
Return any unused portions of the affected medicine to your pharmacy to receive a refund and for proper disposal instructions.
Contact West-Ward Pharmaceuticals or the manufacturer for further instructions regarding this recall.
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 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: Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL (250 mL bottle)

Model:

NDC:0054-0199-59

Recall #: D-1863-2019

Lot Numbers:

AA3957A (exp May 2020)

AA3958A (exp May 2020)

AA5164A (exp Sep 2020)

Date Ranges: May 2020, September 2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83698

Status: Resolved

Manufacturer: West-Ward Columbus Inc

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 32,347 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 medicine bottle for Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL (250 mL per bottle) with the NDC number 0054-0199-59.

Verify if your bottle belongs to one of the affected lots: AA3957A (Expiration May 2020), AA3958A (Expiration May 2020), or AA5164A (Expiration September 2020).

Contact your healthcare provider or pharmacist immediately to discuss a replacement and to ensure your seizure management plan is not interrupted.

Return any unused portions of the affected medicine to your pharmacy to receive a refund and for proper disposal instructions.

Contact West-Ward Pharmaceuticals or the manufacturer for further instructions regarding this recall.

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.