Recalls / Class II
Class IID-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
- Affected lot / code info
- Lot #: 07MA2232, Exp. 4/30/23
Why it was recalled
cGMP deviation: discontinue of stability support for product.
Recalling firm
- Firm
- Direct Rx
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 94 Worldwide Dr, Dawsonville, Georgia 30534-6828
Distribution
- Quantity
- 11 bottles
- Distribution pattern
- FL
Timeline
- Recall initiated
- 2022-11-02
- FDA classified
- 2023-01-11
- Posted by FDA
- 2023-01-18
- Terminated
- 2024-09-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0101-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.