D-0637-2022 Class II Terminated
FDA drug recall D-0637-2022 was initiated by Direct Rx on Feb 17, 2022 and is designated Class II. Reason for recall: Failed impurities/degradation specifications The recall status is terminated (terminated Oct 4, 2023). Affected quantity: 44 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 9, 2022
- Initiation Date
- Feb 17, 2022
- Termination Date
- Oct 4, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 44 bottles
Product Description
Moxifloxacin Ophthalmic Solution USP 0.5%, 3 mL, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Dist. By Aurobindo Pharma USA, Inc. East Windsor, NJ 08520, NDC 72189-076-05
Reason for Recall
Failed impurities/degradation specifications
Distribution Pattern
Florida
Code Information
Lot#: 18JA2218 Exp. 6/30/23; 20DE2104 Exp. 6/30/23; 08NO2111 Exp. 6/30/23
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0637-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026