Drug product
C-PAP/PHEN/PROST/Atrop 150/7.5 (Papaverine 150mg/Phentolamine 7.5mg/Prostaglandin 75mcg/Atropine 1mg injection), 10 ml vial containing 5.9ml solution, Rx, Vital Care Compounder, Hattiesburg, MS
D-1547-2016
Product summary
- Event
- Event 75164
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1vial
- Official record key
drug-enforcement:D-1547-2016
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