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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Affected units
- 44
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
Distributed in 1 state:
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