Drug product
10% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml, b) 10ml c) 15 ml, dropper bottles
D-1854-2019
Product summary
- Event
- Event 83722
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 6x5ml b) 4x10 c) 1x15 ml bottles,
- Official record key
drug-enforcement:D-1854-2019
Official wording
Reason: Lack of Processing Controls:
Code information: Lots: a) 08012019@33 exp: 8/15/19, 07182019@66 exp: 8/01/19, 07182019@15 exp: 8/01/19, 07012019@46 exp. 08/31/19, 07082019@27 exp: 8/31/19, b) 07082019@55 exp: 8/31/19; 07182019@55 exp: 08/31/19; 06242019@55 exp: 8/31/19; 06202019@16 exp: 8/31/19 c) 08052019@11 exp: 11/3/19
Distribution pattern: Product was dispensed to patients
Derived failure modes
-
Manufacturing or process control
Lack of Processing Controls