The Recall Desk
ModerateFDA (Drugs)·D-0637-2022·Announced 2022-03-09

Moxifloxacin Ophthalmic Solution Recalled for Failed Impurity Specifications

Direct Rx is recalling Moxifloxacin Ophthalmic Solution USP 0.5% due to failed impurities and degradation specifications. The recall affects 44 bottles distributed in Florida.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall involving a drug product with failed quality specifications. The source does not report any illnesses, injuries, or hospitalizations, and the hazard is a manufacturing defect rather than a known pathogenic or acutely dangerous condition. Class II recalls without reported harm typically score 2–3; the absence of clinical reports and the pharmaceutical (rather than acute biological) nature of the defect supports a Moderate rating.

Plain-English summary

Direct Rx is recalling Moxifloxacin Ophthalmic Solution USP 0.5%, 3 mL bottles (NDC 72189-076-05) packaged and distributed by Direct Rx in Dawsonville, Georgia, and distributed by Aurobindo Pharma USA, Inc. in East Windsor, New Jersey.

The recall is due to failed impurities and degradation specifications. Three lots are affected: Lot 18JA2218 (expiration 6/30/23), Lot 20DE2104 (expiration 6/30/23), and Lot 08NO2111 (expiration 6/30/23). A total of 44 bottles were distributed to Florida.

Patients using affected bottles should contact their healthcare provider or pharmacist for guidance. Direct Rx initiated this Class II recall.

The recalled product

Product
Moxifloxacin Ophthalmic Solution USP 0.5%, 3 mL, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Dist. By Aurobindo Pharma USA, Inc. East Windsor, NJ 08520, NDC 72189-076-05
Manufacturer
Direct Rx
Category
Drug — Ophthalmic Solution
Hazard
  • failed-quality-specifications
  • impurities
  • degradation

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lot#: 18JA2218 Exp. 6/30/23
  • 20DE2104 Exp. 6/30/23
  • 08NO2111 Exp. 6/30/23

Distribution

Distribution scope not specified by the agency.

Related recalls

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