Medications & Supplements/Prescription Drugs

Preferred Pharmaceuticals, Inc: Neomycin, Polymyxin, and Dexamethasone Eye Ointment Recalled for Quality Issues

Agency Publication Date: July 22, 2019

Summary

Preferred Pharmaceuticals, Inc. has recalled 171 tubes of Neomycin Sulfate 3.5 mg/Polymyxin B Sulfate 10,000 units/Dexamethasone 1 mg Ophthalmic Ointment (a generic version of Maxitrol). This voluntary recall was initiated because the manufacturing facility had insufficient quality control over critical systems used to make the medication. Consumers who have this prescription eye ointment should be aware that these manufacturing deviations could compromise the quality and safety of the product.

Risk

The lack of adequate quality assurance controls over critical manufacturing systems may result in a product that does not meet safety or purity standards, potentially leading to ineffective treatment or unintended irritation when applied to the eye.

What You Should Do

Check your prescription eye ointment packaging for the NDC number 68788-9373-03 to see if it is the affected Neomycin Sulfate 3.5 mg/Polymyxin B Sulfate 10,000 units/Dexamethasone 1 mg Ophthalmic Ointment.
Verify the lot and batch numbers on the tube or box; affected units include Lot L2117Q (Batch 12211717, Exp. 09/2019), Lot F2818H (Batch 06281808, Exp. 11/2019), and Lot B1819T (Batch B1819T001 to B1819T048, Exp. 05/2020).
Immediately contact your healthcare provider or pharmacist for guidance on whether you should continue using your current tube or obtain a replacement prescription.
Return any unused or affected ointment tubes to the pharmacy where you purchased them to inquire about a refund.
Contact Preferred Pharmaceuticals, Inc. at their Anaheim, CA facility for further instructions regarding this recall.
For additional information or to report adverse effects, 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

Pharmacy refund and healthcare consultation

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

Affected Products

Product: Neomycin Sulfate 3.5 mg/Polymyxin B Sulfate 10,000 units/Dexamethasone 1 mg Ophthalmic Ointment (3 g Tube)

Model:

NDC 68788-9373-03

Recall #: D-1491-2019

Lot Numbers:

L2117Q (Batch 12211717)

F2818H (Batch 06281808)

B1819T (Batch B1819T001 to B1819T048)

Date Ranges: Exp. 09/2019, Exp. 11/2019, Exp. 05/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83370

Status: Resolved

Manufacturer: Preferred Pharmaceuticals, Inc

Sold By: The Physicians Solutions

Manufactured In: United States

Units Affected: 171 tubes

Distributed To: California, Florida

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 eye ointment packaging for the NDC number 68788-9373-03 to see if it is the affected Neomycin Sulfate 3.5 mg/Polymyxin B Sulfate 10,000 units/Dexamethasone 1 mg Ophthalmic Ointment.

Verify the lot and batch numbers on the tube or box; affected units include Lot L2117Q (Batch 12211717, Exp. 09/2019), Lot F2818H (Batch 06281808, Exp. 11/2019), and Lot B1819T (Batch B1819T001 to B1819T048, Exp. 05/2020).

Immediately contact your healthcare provider or pharmacist for guidance on whether you should continue using your current tube or obtain a replacement prescription.

Return any unused or affected ointment tubes to the pharmacy where you purchased them to inquire about a refund.

Contact Preferred Pharmaceuticals, Inc. at their Anaheim, CA facility for further instructions regarding this recall.

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