Lupin Recalls Moxifloxacin Ophthalmic Solution Due to Stability Test Failures
Lupin Pharmaceuticals is recalling Moxifloxacin Ophthalmic Solution because out-of-specification test results were found in a long-term stability study.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The hazard is a failed impurity specification in a stability study, which is a quality control issue rather than a direct, reported safety incident.
Plain-English summary
Lupin Pharmaceuticals, Inc. is recalling Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL dropper bottles. The recall involves 43,860 bottles with lot numbers H705562, H705563, and H800616.
The recall was initiated because out-of-specification test results for related substances were obtained during a three-month long-term stability study. The product was distributed by 5 wholesalers, 6 drug chains, 4 mail order pharmacies, and 1 mail order pharmacy/supermarket, which may have further distributed the product throughout the United States.
Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on alternatives or replacement.
The recalled product
- Product
- MOXIFLOXACIN (MOXIFLOXACIN)
- Brand
- MOXIFLOXACIN
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Ophthalmic
- Hazard
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 (5)
- Lot Numbers: H705562
- H705563
- EXP. 11/2019
- H800616
- EXP. 01/2020
UPCs (1)
- 0368180422013
Distribution
Distribution scope not specified by the agency.
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