Drug product
PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 90MG/3MG/29.4MCG/ BOTTLE SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
D-0045-2023
Product summary
- Event
- Event 90982
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2 vials
- Official record key
drug-enforcement:D-0045-2023
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: 66450, BUD: 11/07/2022; 66527, BUD: 11/09/2022
Distribution pattern: AL, LA, MS, and TN
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility