Drug product
C-PAP/PHEN/PROST/ATROP 150/5/5 (Papaverine 150mg/Phentolamine 5mg/Prostaglandin 50mcg/Atropine 0.04mg injection), Rx, 10 ml vials contain 5.8 ml solution, Vital Care COMPOUNDER, Hattiesburg, MS 39402
D-1545-2016
Product summary
- Event
- Event 75164
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 vial
- Official record key
drug-enforcement:D-1545-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot# 397877, USE BY 1-6-17
Distribution pattern: MS
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility