Drug product
Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per bottle, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Distributed By: MWI Boise, ID 83705, NDC: 13985-611-15
D-0154-2023
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 90948
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 23,026 bottles
- Official record key
drug-enforcement:D-0154-2023
Official wording
Reason: CGMP Deviations:
Code information: Lot: 0L53A, EXP 10/31/2022; 1J49A, EXP 8/31/2023;
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations