Moxifloxacin Ophthalmic Solution 0.5% Recall: CGMP Deviations
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
What is the FDA recall status?
The FDA record lists this recall as terminated. This does not establish that a retained recalled product is safe to consume or use. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions.
Why was Moxifloxacin Ophthalmic Solution 0.5% recalled?
cGMP deviation: discontinue of stability support for product.
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Full product description
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
Which lot codes, UPCs or models are affected?
Lot #: 07MA2232, Exp. 4/30/23
- Agency record number
- D-0101-2023
- 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
- Recalling firm
- Direct Rx
- Quantity
- 11 bottles
- Distribution
- FL
- Recall started
- November 2, 2022
- Report date
- January 18, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)