Drug product
PAPAVERINE-PHENTOLAMINE-PGE1 23-0.96MG-19.2MCG/ML INJECTABLE, (a) 5ml, (b) 6.5ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330
D-1096-2019
Product summary
- Event
- Event 82278
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 prescription 5, 6.5 ml injection
- Official record key
drug-enforcement:D-1096-2019
Official wording
Reason: Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Code information: Lot: (a) 22102018@31, (b) 09112018@33, 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