Drug product
TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops, 30 Sterile Single-Use Vials per box, Akorn Consumer Health, A Division of Akorn, Inc., Ann Arbor, MI 48105. NDC 58790-010-30
D-0717-2022
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 89836
- Status
- Terminated
- Classification
- Class II
- Quantity
- 62,331 box
- Official record key
drug-enforcement:D-0717-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 913012, 913013, 913014, Exp. Date 1/31/2023
Distribution pattern: Nationwide within theUSA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility