Drug product
DEXAMETHASONE (NAPO4) 0.1% OPHTH* PRES-FREE SOLUTION, 10ml, Eye Drops, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330
D-1087-2019
Product summary
- Event
- Event 82278
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12 prescriptions
- Official record key
drug-enforcement:D-1087-2019
Official wording
Reason: Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Code information: Lots: 23012019@48, 24012019@2, 24012019@36, 28012019@35, 29012019@13, 05022019@5, 11022019@13, 12022019@20, 19022019@1, 19022019@6, 19022019@57, 19022019@61, All lots within expiry 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