D-0101-2023 Class II Terminated
FDA drug recall D-0101-2023 was initiated by Direct Rx on November 2, 2022 and is designated Class II. Reason for recall: cGMP deviation: discontinue of stability support for product. The recall status is terminated (terminated September 30, 2024). Affected quantity: 11 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- January 18, 2023
- Initiation Date
- November 2, 2022
- Termination Date
- September 30, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11 bottles
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
Reason for Recall
cGMP deviation: discontinue of stability support for product.
Distribution Pattern
FL
Code Information
Lot #: 07MA2232, Exp. 4/30/23