Drug product
GLYCERIN OPHTHALMIC DROPS 98.5% Solution, 10 mL droptainer, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
D-0033-2023
Product summary
- Event
- Event 90982
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 droptainer
- Official record key
drug-enforcement:D-0033-2023
Official wording
Reason: 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.
Code information: Lot: 65416, BUD: 10/13/2022
Distribution pattern: AL, LA, MS, and TN
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility