Drug product
ActivEyes Sterile Altalube Ointment, Net Wt 1/8 oz (3.5g), NDC 59390-198-50
D-0418-2020
Product summary
- Event
- Event 83265
- Status
- Completed
- Classification
- Class II
- Quantity
- 161077 units
- Official record key
drug-enforcement:D-0418-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: RJH 10/20 1/10/2018 RLL 12/20 8/22/2018 SGH 07/21 8/23/2018 SIF 09/21 10/16/2018 SKC 11/21 12/12/2018 TCG 03/22
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility