D-0031-2023 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
- 460 syringes
Product Description
CEFUROXIME INTRAVITREAL SYR 1MG/0.1ML Solution in 1 mL syringe, 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: 63265, BUD: 01/24/2023; 66085, BUD: 04/03/2023