Moxifloxacin Ophthalmic Solution Recalled Due to Manufacturing Quality Deviation
Direct Rx recalled 11 bottles of Moxifloxacin Ophthalmic Solution (0.5%, 3 mL) due to a cGMP deviation and discontinued stability support.
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 with no reported illnesses or injuries and no documented safety incident. The hazard is a manufacturing quality deviation with discontinued stability support, which constitutes a precautionary recall rather than an immediate known safety threat.
Plain-English summary
Direct Rx, LLC is recalling 11 bottles of Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL (NDC 72189-0334-05, Lot #07MA2232, expiring 4/30/23) that were distributed in Florida. The recall was issued due to a current Good Manufacturing Practice (cGMP) deviation and the discontinuation of stability support for the product.
Patients who have this product should consult their healthcare provider about whether they may have been affected. The affected product should not be used. Patients with questions should contact Direct Rx, LLC at the address on the packaging or speak with their healthcare provider or pharmacist.
The recalled product
- Product
- Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distributed By: Direct Rx, LLC 94 Worldwide Drive, Dawsonville, GA 30534, NDC 72189-0334-05
- Manufacturer
- Direct Rx
- Category
- Drug — Ophthalmic
- Affected units
- 11
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 (2)
- Lot #: 07MA2232
- Exp. 4/30/23
Distribution
Distributed in 1 state:
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