Drug product
Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bottle, Akorn, Inc., Lake Forest, IL 60045, NDC 17478-623-12.
D-0124-2017
Product summary
- Firm
- Akorn Inc
- Event
- Event 75418
- Status
- Terminated
- Classification
- Class II
- Quantity
- 29,972 bottles
- Official record key
drug-enforcement:D-0124-2017
Official wording
Reason: Subpotent Drug: concentration of product is less than labeled amount.
Code information: Lot: 041306A, Exp 04/19
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Subpotent