Moxifloxacin Ophthalmic Solution Recall for Failed Impurities Specifications
Aurobindo Pharma USA Inc. is recalling Moxifloxacin Ophthalmic Solution 0.5% due to failed impurities and degradation specifications. The recall affects 115,776 bottles distributed nationwide.
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 for a manufacturing/quality defect (failed impurities and degradation specifications). The source text does not report any illnesses, injuries, or hospitalizations. The hazard is related to product quality specifications rather than an acute safety threat, consistent with a Moderate severity classification.
Plain-English summary
Aurobindo Pharma USA Inc. is recalling Moxifloxacin Ophthalmic Solution, USP 0.5% w/v, 3 mL bottles because the product failed to meet impurities and degradation specifications.
The recalled product is a prescription eye medication distributed nationwide under the following identifiers: NDC 65862-840-03, Lot numbers CMF210001, CMF210003, and CMF210004 with expiration date 6/2023. Approximately 115,776 bottles have been distributed.
Consumers and healthcare providers should discontinue use of affected lots and contact Aurobindo Pharma USA Inc. for replacement or refund. Patients should consult their healthcare provider if they have used this medication and have concerns about their treatment.
The recalled product
- Product
- MOXIFLOXACIN (MOXIFLOXACIN)
- Brand
- MOXIFLOXACIN
- Manufacturer
- Aurobindo Pharma USA Inc.
- Hazard
- impurity-degradation
- quality-specification-failure
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 (4)
- Lot#: CMF210001
- CMF210003
- CMF210004
- Exp 6/2023
UPCs (1)
- 0365862840035
Distribution
Distributed nationwide across the United States.
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