D-0051-2023 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- November 9, 2022
- Initiation Date
- October 7, 2022
- Termination Date
- N/A
- 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