Medications & Supplements/Prescription Drugs

Direct Rx Moxifloxacin Ophthalmic Solution Recalled for Impurity Issues

Agency Publication Date: February 25, 2022

Summary

Direct Rx is recalling 44 bottles of Moxifloxacin Ophthalmic Solution USP 0.5% (3 mL), a prescription antibiotic eye drop used to treat bacterial infections. The recall was issued because the medication failed to meet specifications for purity and degradation. No injuries or incidents related to this issue have been reported to date.

Risk

The presence of impurities or degradation in the solution may reduce the effectiveness of the treatment or cause unintended irritation to the eye.

What You Should Do

This recall involves 3 mL bottles of Moxifloxacin Ophthalmic Solution USP 0.5% sold under the Direct Rx brand (NDC 72189-076-05).
Check the bottle or packaging for lot numbers 18JA2218, 20DE2104, or 08NO2111, all with an expiration date of June 30, 2023.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Moxifloxacin Ophthalmic Solution USP 0.5% (3 mL)

Variants: 0.5%, 3 mL

Lot Numbers:

18JA2218 (Exp. 6/30/23)

20DE2104 (Exp. 6/30/23)

08NO2111 (Exp. 6/30/23)

NDC:

72189-076-05

Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Dist. By Aurobindo Pharma USA, Inc. East Windsor, NJ 08520

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89642

Status: Resolved

Manufacturer: Direct Rx

Sold By: Aurobindo Pharma USA, Inc.; Direct Rx

Manufactured In: United States

Units Affected: 44 bottles

Distributed To: 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

This recall involves 3 mL bottles of Moxifloxacin Ophthalmic Solution USP 0.5% sold under the Direct Rx brand (NDC 72189-076-05).

Check the bottle or packaging for lot numbers 18JA2218, 20DE2104, or 08NO2111, all with an expiration date of June 30, 2023.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information.