Drug product
Papaverine 150 mg / Phentolamine 5 mg vials, packaged 5.5 mL in a sterile, clear 10 mL MDV, Rx only, Sterile Injection, Vital Care Compounder, Hattiesburg, MS 39402
D-1534-2016
Product summary
- Event
- Event 75164
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 vials
- Official record key
drug-enforcement:D-1534-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot# 386184, Use by 08-03-16
Distribution pattern: MS
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility