Drug product
Papaverine 150 mg/Phentolamine 5 mg and Prostaglandin 50 mcg, packaged as 5.5 mL in a 10 mL MDV, Rx only, Vital Care Compounder, Hattiesburg, MS 39402
D-1535-2016
Product summary
- Event
- Event 75164
- Status
- Terminated
- Classification
- Class II
- Quantity
- 386606 - 3 vials, 393302 - 3 vials
- Official record key
drug-enforcement:D-1535-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot#: 386606, Use by 8-9-16, 393302, Use by 10-28-16
Distribution pattern: MS
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility