D-0051-2023 Class II Ongoing
FDA drug recall D-0051-2023 was initiated by Pharmacy Plus, Inc. Dba Vital Care Compounder on Oct 7, 2022 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile. The recall status is ongoing. Affected quantity: 378 droptainers.
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 9, 2022
- Initiation Date
- Oct 7, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 378 droptainers
Product Description
PRED ACETATE / GATIFLOXACIN 1% / 0.5% SUSP, 10 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Reason for Recall
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Distribution Pattern
AL, LA, MS, and TN
Code Information
Lots: 65056, BUD: 11/18/2022; 66246, BUD: 11/19/2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0051-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026