Drug product
PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 150MG/10MG/100MCG/ BOTTLE SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
D-0043-2023
Product summary
- Event
- Event 90982
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 vial
- Official record key
drug-enforcement:D-0043-2023
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: 66576, BUD: 11/09/2022
Distribution pattern: AL, LA, MS, and TN
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility