Drug product
20% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in 3ml dropper bottle.
D-1853-2019
Product summary
- Event
- Event 83722
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3x3 ml dropper bottles
- Official record key
drug-enforcement:D-1853-2019
Official wording
Reason: Lack of Processing Controls:
Code information: Lots: 07172019@39 exp: 8/31/19, Rx # 215042 06192019@28 exp: 7/03/19, Rx # 219335 06052019@8 exp: 6/19/19; Rx # 222826
Distribution pattern: Product was dispensed to patients
Derived failure modes
-
Manufacturing or process control
Lack of Processing Controls