Drug product
PAPAVERINE-PHENTOLAMINE-PGE1 30-1.6 MG-16 MCG/ML* INJECTABLE, (a) 5ml, (b) 10ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
D-1097-2019
Product summary
- Event
- Event 82278
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 prescription 5, 10 ml injection
- Official record key
drug-enforcement:D-1097-2019
Official wording
Reason: Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Code information: Lot: 05102018@36,27112018@49, (b) 28112018@54, distributed between 09-01-2018 to 02-20-2019.
Distribution pattern: Dispensed in Oregon
Derived failure modes
-
Manufacturing or process control
Lack of Processing Controls