Drug product
PAPAVERINE-PHENTOLAMINE-PGE1 12-1MG-10MCG/ML INJECTABLE, (a) 10ml, (b) 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330
D-1094-2019
Product summary
- Event
- Event 82278
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9 prescriptions 10, 9ml injection
- Official record key
drug-enforcement:D-1094-2019
Official wording
Reason: Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Code information: Lot (a)17102018@15,14112018@3, 04122018@21, 14122018@15, 7122018@11, 28122018@69, 20092018@2, (b) 21012019@37, 22012019@31, 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