Drug product
5% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml , b) 10ml dropper bottles
D-1855-2019
Product summary
- Event
- Event 83722
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 4x5 ml, b) 1x10 ml bottles
- Official record key
drug-enforcement:D-1855-2019
Official wording
Reason: Lack of Processing Controls:
Code information: Lots a) 07182019@29 exp: 8/31/19, 07082019@2 exp: 8/31/19, 06052019@21 exp:08/31/19 06062019@52 exp: 6/25/19; b) 07022019@28 exp: 8/31/19
Distribution pattern: Product was dispensed to patients
Derived failure modes
-
Manufacturing or process control
Lack of Processing Controls