Medications & Supplements/Prescription Drugs

Direct Rx Moxifloxacin Ophthalmic Solution Recalled for Manufacturing Issues

Agency Publication Date: January 11, 2023

Summary

Direct Rx is recalling 11 bottles of Moxifloxacin Ophthalmic Solution (0.5%, 3 mL), a prescription medication used to treat bacterial eye infections. The recall was issued because the manufacturer stopped providing stability support for the product, which is a manufacturing deviation. Consumers who have used this medication and have health concerns should contact their healthcare provider or pharmacist.

Risk

Because the product no longer has stability support, its effectiveness, strength, and quality cannot be guaranteed through its expiration date. There have been no reports of incidents or injuries related to this recall.

What You Should Do

This recall affects 11 bottles of Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL (NDC 72189-0334-05) packaged and distributed by Direct Rx, LLC.
Identify the affected product by checking the packaging for lot number 07MA2232 with an expiration date of 4/30/23.
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 Direct Rx for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more information regarding this recall.

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, 0.5% (3 mL)

Variants: 0.5%, 3 mL, Rx Only

Lot Numbers:

07MA2232 (Exp. 4/30/23)

NDC:

72189-0334-05

Recall #: D-0101-2023

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91114

Status: Resolved

Manufacturer: Direct Rx

Sold By: Direct Rx, LLC

Manufactured In: United States

Units Affected: 11 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 affects 11 bottles of Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL (NDC 72189-0334-05) packaged and distributed by Direct Rx, LLC.

Identify the affected product by checking the packaging for lot number 07MA2232 with an expiration date of 4/30/23.

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 Direct Rx for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more information regarding this recall.