Drug product
Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-711-31
D-1495-2022
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 90813
- Status
- Terminated
- Classification
- Class II
- Quantity
- 82,689 tubes
- Official record key
drug-enforcement:D-1495-2022
Official wording
Reason: cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
Code information: Lot # 9J36A, 9J36B, 9J39A, 9J39B, 9J39C, 9J39D, 9J39E, 9J42B, 9J42C, Exp 8/31/2022; 9K62A, 9K62B, 9K62C, Exp 9/30/2022; 9M04A, 9M04B, Exp 11/30/2022
Distribution pattern: USA nationwide
Derived failure modes
-
Manufacturing or process control
cGMP Deviations