Drug product
PGE1-LIDOCAINE 40 MCG-1% /ML* INJECTABLE, (a) 10 ml (b) 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
D-1098-2019
Product summary
- Event
- Event 82278
- Status
- Terminated
- Classification
- Class II
- Quantity
- 25 prescriptions 10, 9, ml injectable
- Official record key
drug-enforcement:D-1098-2019
Official wording
Reason: Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Code information: Lot:(a) 26092018@22, 26092018@22, 09102018@47, 15102018@33, 15102018@33, 09102018@47, 15102018@33, 09102018@47, 29112018@4, 10122018@14, 29112018@4, 29112018@4, 19122018@20, 21122018@29, 21122018@29, 27122018@20, (b) 16012019@59, 18012019@17, 21012019@49, 21012019@49, 22012019@24, 22012019@24, 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