Drug product
PAPAVERINE-PHENTOLAMINE-PGE1 30-1 MG-20 MCG/ML* INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
D-1107-2019
Product summary
- Event
- Event 82278
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 prescriptions, 5ml injectable
- Official record key
drug-enforcement:D-1107-2019
Official wording
Reason: Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Code information: Lot:20092018@41, 25092018@7, 27092018@3, 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