Drug product
PAPAVERINE / PHENTOLAMINE INJECTION 150MG / 5MG / VIAL SOLUTION, 10 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
D-0046-2023
Product summary
- Event
- Event 90982
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 242 vials
- Official record key
drug-enforcement:D-0046-2023
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: Lots: 55092, BUD: 10/22/2022; 59100, BUD: 10/30/2022; 62038, BUD: 04/08/2023; 66533, BUD: 04/08/2023
Distribution pattern: AL, LA, MS, and TN
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility