Drug product
ADAA Cataract Drops, (Lido 1.47%, Phenyleph 0.294% Cyclopentolate 0.147%, Tropicamide 0.0735%, Moxiflox 0.0294%, Ketorolac 0.0147%) 1x 1cc syringe, Westlab Pharmacy, Inc., Gainesville, FL 32607 --- NDC 10002-2579-05
D-0090-2019
Product summary
- Event
- Event 80838
- Status
- Terminated
- Classification
- Class II
- Quantity
- 222 syringes
- Official record key
drug-enforcement:D-0090-2019
Official wording
Reason: Lack of Process Controls
Code information: Lot: 06182018@30 Exp. 08/28/2018
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
Lack of Process Controls